FDA Cleared AI Algorithms

Aidoc Briefcase- ICH and PE triage

Aidoc Medical, Ltd

Indications for Use	BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced CT and CTPA images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of Intracranial Hemorrhage and Pulmonary Embolism pathologies. For the PE pathology, the software is only intended to be used on single-energy exams.
Product Code	QAS
Body Area	Head and Chest
Modality	CT, CTPA
Predicate Device	BriefCase (K180647, for ICH triage)
Product Performance	Aidoc conducted a retrospective, blinded, multicenter, multinational study with the BriefCase software with the primary endpoint to evaluate the software's performance in identifying CTPAs containing pulmonary embolism in 184 cases from 3 clinical sites. Sensitivity and specificity exceeded the 80% performance goal. Specifically, sensitivity was observed to be 90.6% and specificity was observed to be 89.9%. A secondary endpoint measure was Briefcase's potential clinical benefit of worklist prioritization for true positive PE cases. The BriefCase time-to-notification for PE was 3.9 minutes, while the standard of care time-to-exam-open was 64.1 minutes.
Clinical Validation	The company conducted a retrospective evaluation of 2,803 CT pulmonary angiogram (CTPA) exams of patients with suspected PE, from a single center. The goal of this study was primarily to demonstrate that the BriefCase software can identify PE with high accuracy. Ground truth was determined by a review of a single radiologist and the radiology report. Another radiologist was used to break ties between the report and the reviewer. Sensitivity was 93.0% and specificity was 93.7%.
Related Use Cases	Pulmonary Embolism

FDA cleared 4/15/2019

Aidoc conducted a retrospective, blinded, multicenter, multinational study with BriefCase software with the primary endpoint to evaluate the software’s performance in identifying non contrast CT head images containing ICH findings in 1198 cases form 3 clinical sites. Sensitivity and specificity exceeded the 80 % performance goal. Sensitivity was observed to be 93.6% and specificity was observed to be 92.3%.

A secondary endpoint measure was Briefcase’s potential clinical benefit of worklist prioritization for true positive ICH cases. The standard of care time-to-exam-open is 72.6 minutes. With BriefCase software the time-to-notification is 4.46 minutes.

Aidoc conducted a retrospective, blinded, multicenter, multinational study with BriefCase software with the primary endpoint to evaluate the software’s performance in identifying non contrast CT head images containing ICH findings in 1198 cases form 3 clinical sites. Sensitivity and specificity exceeded the 80 % performance goal. Sensitivity was observed to be 93.6% and specificity was observed to be 92.3%.

A secondary endpoint measure was Briefcase’s potential clinical benefit of worklist prioritization for true positive ICH cases. The standard of care time-to-exam-open is 72.6 minutes. With BriefCase software the time-to-notification is 4.46 minutes.

Aidoc BriefCase-IFG

Aidoc Medical, Ltd.

Indications for Use	BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of Intra-abdominal free gas (IFG) pathologies. BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings.
Product Code	QAS
Body Area	Abdomen
Modality	CT
Predicate Device	BriefCase for ICH
Product Performance	None
Clinical Validation	Aidoc conducted a retrospective, blinded, multicenter, multinational study with the BriefCase software with the primary endpoint to evaluate the software's performance in identifying abdominal CTs containing Intra-abdominal Free Gas.
Related Use Cases	None

FDA cleared 6/19/2020

AIMI-Triage CXR PTX

RadLogics, Inc.

Indications for Use	The AIMI-Triage CXR PTX Application is a notification-only triage workflow toll for use by hospital networks and clinics to identify and help prioritize chest X-rays acquired in the acute setting for review by hospital radiologists. Specifically, the device uses an artificial intelligence algorithm to analyze images for features suggestive of moderate to large sized pneumothorax; it makes case-level output available to a PACS/workstation for worklist prioritization or triage.
Product Code	QFM
Body Area	Chest
Modality	X-Ray
Predicate Device	HealthPNX
Product Performance	None
Clinical Validation	The AIMI-Triage CXR PTX was evaluated and verified in a blinded, retrospective and multi-center study for detecting pneumothorax in chest X-rays. A total of 300 frontal chest X-rays were collected from US and OUS patients representative of the intended population. The AIMI-Triage CXR PTX output was compared to the ground truth established by 3 independent US-board certified radiologists.
Related Use Cases	Pneumothorax

FDA cleared 4/8/2020

AI-Rad Companion Brain MR

Siemens Medical Solutions USA, Inc.

Indications for Use	Post-processing image analysis software that assists clinicians in viewing, analyzing and evaluating MR brain images. Functionalities include: automatic segmentation and quantitative analysis of individual brain structures, quantitative comparison of each brain structure with normative data from a healthy population, and presentation of results for reporting that includes all numerical values as well as visualization of these results.
Product Code	LLZ
Body Area	Head
Modality	MR
Predicate Device	Syngo.MR Applications
Product Performance	Software validations, bench testing, and clinical data-based software validations have been conducted to the performance claims as well as the claim of substantial equivalence to the predicate devices.
Clinical Validation	None.
Related Use Cases	None

FDA cleared 6/17/2020

AI-Rad Companion- Cardiovascular

Siemens Medical Solutions USA, Inc.

Indications for Use	Software provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of cardiovascular diseases.
Product Code	JAK, LLZ
Body Area	Heart
Modality	CT
Predicate Device	syngo.CT Calcium Scoring (K990426), syngo.CT Cardiac Function (K123585)
Product Performance	Software validations, bench testing, and clinical data-based software validations have been conducted to the performance claims as well as the claim of substantial equivalence to the predicate devices.
Clinical Validation	For clinical validation the following algorithms underwent a scientific evaluation: Segmentation of heart, detection of coronary calcium, segmentation of aorta, detection of aortic landmarks, aorta diameter measurements, and threshold-based categorization of diameter measurements. The performance of the device has been validated in retrospective performance studies on non-cardiac chest CT data from multiple clinical sites across US.
Related Use Cases	None

FDA cleared 9/10/2019

AI-Rad Companion- Musculoskeletal

Siemens Medical Solutions USA, Inc.

Indications for Use	Software provides quantitative and qualitative analysis of previously acquired CT DICOM images to support radiologists and physicians in the evaluation and assessment of musculoskeletal disease.
Product Code	JAK
Body Area	Spine
Modality	CT
Predicate Device	syngo.CT Bone Reading
Product Performance	Software validations, bench testing, and clinical data-based software validations have been conducted to the performance claims as well as the claim of substantial equivalence to the predicate devices.
Clinical Validation	For clinical validation, the algorithms for vertebrae segmentation, vertebra height and vertebra density measurements underwent scientific evaluation. The device has been validated in retrospective performance study on chest CT data. Performance was consistent for all critical subgroups, such as vendors or reconstruction parameters and patient age.
Related Use Cases	None

FDA cleared 3/16/2020

AI-Rad Companion Prostate MR

Siemens Medical Solutions USA, Inc.

Indications for Use	AI-Rad Companion Prostate MR is a post-processing image analysis software that assists clinicians in viewing, manipulating, analyzing, and evaluating MR prostate images.
Product Code	QIH, LNH
Body Area	Prostate
Modality	MR
Predicate Device	Syngo.MR Applications
Product Performance	Software validation and bench testing have been conducted
Clinical Validation	None
Related Use Cases	None

FDA cleared 7/30/2020

AI-Rad Companion-Pulmonary

Siemens Medical Solutions USA, Inc.

Indications for Use	Software provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of disease of the lungs.
Product Code	JAK, LLZ
Body Area	Lungs
Modality	CT
Predicate Device	syngo.CT Pulmo 3D (K123540)
Product Performance	Software validations, bench testing, and clinical data-based software validations have been conducted to the performance claims as well as the claim of substantial equivalence to the predicate devices.
Clinical Validation	For clinical validation the algorithms segmentation of lung lobes and evaluation of the lung parenchyma underwent scientific evaluation. Pulmonary device has been validated in a retrospective performance study (n > 4,500 CT data sets from multiple clinical sites from within and outside US). All performance results were superior to the ones achieved using the predicate device supporting substantial equivalence.
Related Use Cases	None

FDA cleared 7/26/2019

AlphaPoint Imaging Software

RadLogics, Inc.

Indications for Use	The AlphaPoint software is a device that allows review, analysis, and interchange of CT chest images. The software provides segmentation and hounsfield numerical analysis values which are indicative of various substances.
Product Code	LLZ
Body Area	Chest
Modality	CT
Predicate Device	Vitrea 2 (K060378)
Product Performance	The AlphaPoint software has been verified and validated according to the company's design control process. It was tested for compliance with the DICOM standard and passed the six DICOM specific test cases provided in section 4.4.4.2 of the Validation Test Report. The software development process complies with FDA Guidance documents related to software in Medical Devices.
Clinical Validation	None
Related Use Cases	None

FDA cleared 4/13/2012

Arterys Cardio DL

Arterys, Inc.

Indications for Use	Arterys Cardio DL is a web-accessible image post-processing analysis software device used for viewing and quantifying cardiovascular MR images. The device is intended to visualize and quantify MRI data in DICOM format.
Product Code	LLZ
Body Area	Heart
Modality	MR
Predicate Device	Arterys Software v2.0 , Medis Imaging QMass
Product Performance	Safety and performance of Arterys Cardio DL has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing.
Clinical Validation	None
Related Use Cases	Flow in Ascending Aorta (Partial) , Flow in Pulmonary Artery(Partial) , Pulmonary to Systemic Flow Ratio(Partial), Left Ventricle Volume(Partial), Cardiac Outputs(Partial)

FDA cleared 1/5/2017

Arterys Oncology DL

Arterys Inc.

Indications for Use	Arterys Oncology DL is a medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points.
Product Code	LLZ
Body Area	All
Modality	CT,MR
Predicate Device	syngo TrueD (K101749)
Product Performance	The safety and performance of Arterys Oncology DL has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Non-clinical verification and validation test results established that the device meets its design requirements and intended use, that it is as safe and as effective as the predicate devices, and that no new issues of safety and effectiveness were raised.
Clinical Validation	None
Related Use Cases	None

FDA cleared 1/25/2018

Broncholab

Fluidda Inc.

Indications for Use	Broncholab provides physicians with reproducible CT values for pulmonary tissue for providing quantitative support for diagnosis and follow-up examination. Broncholab can be used to support physicians in the diagnosis and documentation of pulmonary tissues images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of subcompartments, volumetric analysis, density evaluations, low density cluster analysis, fissure evaluation and reporting tools are combined with a dedicated workflow.
Product Code	JAK
Body Area	Chest
Modality	CT
Predicate Device	VIDA Pulmonary Workstation 2
Product Performance	Verification testing was conducted against predetermined acceptance criteria to show that the subject device performs the functions that are equivalent to the predicate device. Broncholab successfully passed verification testing. Design validation was performed in simulated use settings. The results support substantial equivalence of the subject device to the predicate device and demonstrate that it is safe and effective for its intended use.
Clinical Validation	None
Related Use Cases	None

FDA cleared 3/4/2020

Caption Interpretation Automated Ejection Fraction Software

Caption Health

Indications for Use	The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation.
Product Code	QIH
Body Area	Heart
Modality	Ultrasound
Predicate Device	EchoMD Automated Ejection Fraction Software
Product Performance	Software verification and validation testing were conducted
Clinical Validation	Caption Interpretation AutoEF was the subject of a pivotal clinical investigation to validate successful performance of the EF calculation in comparison to conventional EF calculation methods.
Related Use Cases	Left Ventricle Volume

FDA cleared 7/22/2020

CINA

AVICENNA.AI

Indications for Use	CINA is a radiological computer aided triage and notification software indicated for use in the analysis of (1) nonenhanced head CT images and (2) CT angiographies of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) head CT images for Intracranial Hemorrhage (ICH) and (2) CT angiographies of the head for large vessel occlusion (LVO). CINA uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) ICH or (2) LVO on a standalone Web application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH or LVO findings.
Product Code	QAS
Body Area	Head
Modality	CT
Predicate Device	BriefCase for ICH
Product Performance	The CINA device has been evaluated and verified in accordance with software specifications and applicable performance standards through Software Development and Validation and Verification process.
Clinical Validation	Avicenna.AI conducted a retrospective, blinded, multicenter, multinational study with the CINA software with the primary endpoint to evaluate the software's performance in CT head images suspected of ICH and CTA head series with suspected LVO findings.
Related Use Cases	None

FDA cleared 6/24/2020

ClearRead and Confirm

Riverain Technologies, LLC.

Indications for Use	ClearRead + Confirm is a dedicated post-processing application that generates an enhanced, secondary digital radiographic image of the chest to facilitate confirmation of line/tubes.
Product Code	LLZ
Body Area	Chest
Modality	Radiograph
Predicate Device	ClearRead Bone Suppression (SoftView) (K092363) , DRX-Revolution (K120062)
Product Performance	Functional verification testing and development validation were conducted to verify that the design output met the design input requirements.
Clinical Validation	Clinical validation was conducted in a MRMC study to validate that the device conformed to the defined user needs and intended uses. The reader study measured the reduction in time required by the radiologists to localize the tips of tubes, lines, and electrical cardiac wires (TLW) when using ClearRead +Confirm., The study also measured the radiologists' accuracy in localizing the TLW when using ClearRead +Confirm. ClearRead Confirm was found to significantly decrease read times in analyses both including and excluding outliers. The difference from true locations in ClearRead Confirmn reads and unaided reads were not found to be statistically significant. The results indicated that ClearRead +Confirm is a useful adjunct for the interpretation of chest radiographs when looking for TLW.
Related Use Cases	None

FDA cleared 12/27/2012

ClearRead CT

Riverain Technologies, LLC

Indications for Use	ClearRead CT™ is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest on an asymptomatic population.
Product Code	OEB, LLZ
Body Area	Chest
Modality	CT
Predicate Device	syngo.CT Lung CAD(K143196) , syngo.PET&CT Oncology(K093621) , ClearRead Bone Suppression (SoftView)(K092363)
Product Performance	None
Clinical Validation	A MRMC was performed to validate that the device conformed to the defined user needs and intended uses. The reader study measured the AUC of the localization ROV response when using ClearRead CT relative to the unaided read. The study also measured the radiologists’ interpretation time when using ClearRead CT relative to unaided interpretations. ClearRead Ct was found to significantly increase the AUC, indicating use of the device is superior to the unaided read for detecting nodules. ClearRead CT was found to decrease read times with and without outliers.
Related Use Cases	Incidental Pulmonary Nodules on CT

FDA cleared 9/9/2016

ClearView cCAD

ClearView Diagnostics, Inc.

Indications for Use	ClearView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images. It automatically classifies shape and orientation characteristics of user-selected regions of interest. this device uses multivariate pattern recognition methods to perform characterization and classification of images.
Product Code	LLZ
Body Area	Breast
Modality	Ultrasound
Predicate Device	BCAD (K050846)
Product Performance	Bench testing was performed to ascertain the degree of concordance with skilled physicians. Ground truth for shape and orientation supplied by three MQSA certified skilled physicians. System was analyzed on 1204 cases which had majority decision on shape and 1227 lesions which had majority decision on orientation. Clearview cCAD system was able to achieve overall accuracy that fell within the 95% confidence interval of the radiologist performance, rendering them statistically equivalent.
Clinical Validation	None
Related Use Cases	Breast Density Quantification(Partial)

FDA cleared 12/28/2016

cmTriage

CureMetrix, Inc.

Indications for Use	A Passive notification for prioritization-only, parallel- workflow software tool used by radiologists to prioritize specific patients within the standard-of-care image worklist for 2D screening mammograms. It flags those that are suggestive of the presence of at least one suspicious finding at the exam level.
Product Code	QFM
Body Area	Breast
Modality	Full Field Digital Mammography (FFDM)
Predicate Device	Viz.AI ContaCT (DEN170073)
Product Performance	None
Clinical Validation	CureMetrix conducted a retrospective, blinded, multi-center study of the cmTriage software. A primary endpoint goal established to validate that cmTriage operates at a 95% CI for both sensitivity and specificity above the 80% CI reported in the BCSC. A secondary endpoint was established to determine time performance of cmTriage to ensure that mammograms can be processed, and notification results returned for use by radiologists within minutes which is clinically acceptable. The dataset consists of 1255 mammographic studies. Overall cmTraiage was able to demonstrate an AUC of .951 with a 95% CI of 0.937 to 0.964 on this dataset.
Related Use Cases	None

FDA cleared 3/8/2019

cNeuro cMRI

Combinostics Oy

Indications for Use	cNeuro cMRI is intended for automatic labeling, quantification and visualization of segmentable brain structures from a set of MR images. The software is intended to automate the current manual process of identifying, labeling and quantifying the segmentable brain structures identified on MR images.
Product Code	LLZ
Body Area	Brain
Modality	MR
Predicate Device	NeuroQuant (K061855), icobrain (K161148)
Product Performance	None
Clinical Validation	To demonstrate the performance of cNeuro cMRI, the compute volumes of brains structures were validated for accuracy and reproducibility. Test data included data from healthy subjects, and patients with neurodegenerative diseases. In the accuracy experiments, cNeuro cMRI fully automated brain segmentation was compared to manually labeled ground truth data. In the reproducibility experiments, the volumes were compared using test-retest data. The experiments included data from 1399 subjects in total.
Related Use Cases	None

FDA cleared 1/8/2018

ContaCT

Viz.ai, Inc.

Indications for Use	ContaCT is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, 2 independent of standard of care workflow.
Product Code	QAS
Body Area	Brain
Modality	CT
Predicate Device	None
Product Performance	VIz.AI conducted a retrospective study to assess the sensitivity and specificity of the image analysis algorithm and notification functionality of ContaCT against a ground truth as established by a neuroradiologist in the detection of large vessel occlusions (LVO) in the brain. Three hundred CT angiogram images were obtained from two clinical sites in the U.S. There were approximately equal numbers of positive and negative cases. All studies were reviewed by neuroradiologists to establish the Ground truth, each study was reviewed to determine if the image contained image features consistent with an LVO, and thus required further review. The sensitivity is 87.8%, specificity 89.6%, and AUC .91. The average time for radiologists to review study is 58.72 minutes in standard of care. While the time to notification average of CotnaCT is 7.32 minutes.
Clinical Validation	None
Related Use Cases	None

FDA cleared 2/13/2018

Critical Care Suite

GE Medical Systems, LLC.

Indications for Use	Computer aided triage and notification device that analyzes frontal chest x-ray images for the presence of prespecified critical findings (pneumothorax). Critical Care Suite identifies images with critical findings to enable case prioritization or triage in the PACS/workstation.
Product Code	QFM
Body Area	Chest
Modality	X-Ray
Predicate Device	HealthPNX (K190362)
Product Performance	None
Clinical Validation	Critical Care suite was evaluated on a dataset of 804 frontal chest X-rays collected in North America and representative of the intended population. The algorithm prediction is compared to the ground truth established by 3 radiologists. The AUC= 96%, sensitivity is 84.35, and specificity is 93.5%.
Related Use Cases	Pneumothorax

FDA cleared 8/12/2019

CT CoPilot

ZepMed, LLC.

Indications for Use	CT CoPilot is intended for automatic labeling, visualization and volumetric quantification of segmentable structures from sets of CT images of the brain. This software is intended to automate the current manual process of identifying, labeling and quantifying structures identified on CT images of the brain and to provide automated registration and reformatting of data.
Product Code	LLZ
Body Area	Head
Modality	CT
Predicate Device	NeuroQuant (K061855)
Product Performance	Various laboratory testing was performed. 1) 100 randomly acquired CT head scans on both normal patients and those with abnormal pathologies. 2) 179 scans from 34 patients with ventriculostomy catheters 3) Laboratory testing of CT CoPilot segmentation reliability demonstrates equivalent test-retest performance as expert manually segmented subjects.
Clinical Validation	None
Related Use Cases	Midline Shift (Partial)

FDA cleared 12/7/2016

CuraRad-ICH

CuraCloud Corporation

Indications for Use	CuraRad-ICH is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial hemorrhage. CuraRad-ICH analyzes cases using deep learning algorithms to identify suspected ICH findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage.
Product Code	QAS
Body Area	Head
Modality	CT
Predicate Device	Accipolx
Product Performance	None
Clinical Validation	CuraCloud conducted a retrospective, blinded, multisite clinical validation study with CuraRad-ICH. The primary endpoint evaluates the performance of the software in identifying ICH findings from non-contrast head CT scans on a validation dataset of 388 CT studies 296 imaging facilities across US.
Related Use Cases	None

FDA cleared 4/13/2020

DeepCT

Deep01 Limited

Indications for Use	DeepCT is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow. DeepCT uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device analyzes non-contrast CT images of the brain acquired in the acute setting and sends notifications to a specialist that a suspected ICH (intracranial hemorrhage) has been identified and recommends review of those images.
Product Code	QAS
Body Area	Head
Modality	CT
Predicate Device	ContaCT, BriefCase
Product Performance	Software verification and validation testing were conducted.
Clinical Validation	Deep01 conducted a retrospective, multicenter, multinational study with the DeepCT software with the primary endpoint to evaluate the software's performance in identifying non-contrast CT head images containing ICH findings in 260 cases from 5 clinical sites.
Related Use Cases	None

FDA cleared 7/10/2019

DeltaView

Riverain Medical Group, LLC.

Indications for Use	DeltaView is a dedicated post-processing application which registers current and prior chest exams to provide an image that shows areas of change.
Product Code	LLZ
Body Area	Chest
Modality	X-Ray
Predicate Device	SoftView(K092363)
Product Performance	None
Clinical Validation	A MRMC was performed. Radiologists interpreted pairs of images in order to compare the radiologists’ ability to detect valid change when they were aided by the DeltaView image. The results indicated that DeltaView should be a useful adjunct for the interpretation of chest radiographs when looking for a change in a lung nodule.
Related Use Cases	None

FDA cleared 12/28/2011

Densitas Densityai

Densitas, Inc.

Indications for Use	Densitas densityai is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. Densitas densityai provides an ACR BI-RADS Atlas 5th Edition breast density category to aid interpreting physicians in the assessment of breast tissue composition.
Product Code	LLZ
Body Area	Breast
Modality	X-Ray, Tomosynthesis
Predicate Device	DM-Density
Product Performance	Results from internal verification and validation testing performed in accordance with Densitas' design control processes confirm that densitas densityai product specifications have been met.
Clinical Validation	None
Related Use Cases	Breast Density Quantification

FDA cleared 2/19/2020

DM-Density

Densitas, Inc.

Indications for Use	DM-Density is a software application intended for use with compatible full field digital mammography systems. DMDensity calculates percent breast density defined as the ratio of fibro-glandular tissue to total breast area estimates. DM-Density provides these numerical values for each breast as well as a density category to aid interpreting physicians in the assessment of breast tissue composition. DM-Density produces adjunctive information. It is not a diagnostic aid.
Product Code	LLZ
Body Area	Breast
Modality	Mammogram
Predicate Device	iReveal® by iCAD, Inc. (formerly M-Vu® by VuCOMP, Inc.) K132742
Product Performance	Results from internal verification and validation testing performed in accordance with Densitas' design control processes confirm that DM-Density product specifications have been met. Verification testing consisted of unit and integrated system level testing. Validation testing relied on expert radiologist visual assessments of mammography density.
Clinical Validation	None
Related Use Cases	Breast Density Quantification(Partial)

FDA cleared 2/23/2018

EchoGo Core

Ultromics Ltd.

Indications for Use	EchoGo Core is intended to be used for quantification and reporting of results of cardiovascular function to support physician diagnosis. EchoGo Core is indicated for use in adult populations.
Product Code	QIH
Body Area	Heart
Modality	Echocardiogram
Predicate Device	TomTec Arena TTA2, EchoMD Automated Ejection Fraction Software
Product Performance	Software verification and validation testing were conducted.
Clinical Validation	A formal retrospective, non-interventional validation study was conducted using over 378 previously acquired studies.
Related Use Cases	Left Ventricle Volume

FDA cleared 11/13/2019

EchoMD Automated Ejection Fraction Software

Bay Labs, Inc.

Indications for Use	EchoMD automated ejection fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using a personal computer or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction.
Product Code	LLZ
Body Area	Heart
Modality	Echocardiography
Predicate Device	LVivo EF Software (K130779)
Product Performance	None
Clinical Validation	A formal retrospective, non-interventional validation study was conducted using over 300 previously-acquired studies where the biplane method of disks ejection fraction was reported. Variability testing was also performed to demonstrate that EchoMD AutoEF performs acceptably with a variety of image clips and frames from the same patient. EchoMD AutoEF ejection fraction measurements were compared to the biplane method ejection fraction, and a root mean square deviation was calculated (8.29%).
Related Use Cases	None

FDA cleared 6/14/2018

FerriSmart Analysis System

Resonance Health Analysis Service Pty Ltd

Indications for Use	FerriSmart is intended to use for measurement of R2 and iron concentration in the liver from MRI scans.
Product Code	PCS
Body Area	Abdomen
Modality	MRI
Predicate Device	FerriScan R2- MRI analysis System (K124065)
Product Performance	None
Clinical Validation	The clinical study had 971 datasets from multiple makes and models of scanner for assessing the performance of the FerriSmart IQX module; assessing the bias and limits of agreement between FerriSmart and FerriScan measurements of LIC on multiple scanners; assessing the diagnostic performance of FerriSmart for predicting FerriScan LIC results above various clinically relevant LIC thresholds on multiple scanners.
Related Use Cases	None

FDA cleared 11/30/2018

FractureDetect (FX)

Imagen Technologies

Indications for Use	FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system.
Product Code	QBS
Body Area	Ankle, Clavicle, Elbow, Femur, forearm, Hip, Humerus, Knee, Pelvis, shoulder, Tibia, Wrist
Modality	X-Ray
Predicate Device	OsteoDetect
Product Performance	Software verification and validation testing were conducted.
Clinical Validation	Imagen conducted a fully-crossed multiple reader, multiple case (MRMC) retrospective reader study to determine the impact of FX on reader performance in diagnosing fractures. 24 clinical readers each evaluated 175 cases.
Related Use Cases	None

FDA cleared 7/30/2020

HealthCCS

Zebra Medical Vision Ltd.

Indications for Use	The HealthCCS Device is intended for use as a non-invasive post-processing software that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. The software can be used to generate reports of the total risk category of coronary calcium.
Product Code	JAK
Body Area	Heart/Chest
Modality	CT
Predicate Device	CSCS-001A Calcium Scoring Package(K072737 )
Product Performance	Safety and performance of the device has been evaluated and verified in accordance with software specifications and applicable performance standards. Software Development and Validation & Verification Processes have been implemented to ensure performance according to specifications, User Requirements and Federal Regulations and Guidance document.
Clinical Validation	The performance of the device has been validated in a retrospective performance study with 249 cases, where the agreement between the 4-level risk categorization of the Health CCS device has been comparted to the ground truth categorization by 3 radiologists. Adequate overall agreement of .89(95% CI: [.85, .92]) as well as adequate agreement per category were reported. The reproducibility was assessed on 150 studies that were read three times. All Agatston equivalent scores per study were found identical over all three readings.
Related Use Cases	Coronary Calcium Detection

FDA cleared 6/13/2018

HealthCXR

Zebra Medical Vision, Ltd.

Indications for Use	The Zebra HealthCXR device is a software workflow tool designed to aid the clinical assessment of adult Chest X-ray cases with features suggestive of pleural effusion in the medical care environment.
Product Code	QFM
Body Area	Chest
Modality	X-Ray
Predicate Device	HealthPNX (K190362)
Product Performance	None
Clinical Validation	The performance of the HealthCXR device has been validated in a performance study for triage of time sensitive chest X-Ray cases. The data included a retrospective cohort of 554 anonymized Chest X-ray cases from the USE and Israel. The validation data set was truthed by three US Board-Certified Radiologists. Overall the AUC was .9885. The sensitivity and specificity of the HealthCXR was reported for two operating points, the first for equal sensitivity and specificity and the second operating point for a higher specificity. The first operating point showed a sensitivity of 96.74% and specificity of 93.17%. The second, "high-specificity" operating point, reported a sensitivity of 93.84% and a specificity of 97.12%.
Related Use Cases	None

FDA cleared 11/26/2019

HealthICH

Zebra Medical Vision Ltd.

Indications for Use	The Zebra Head CT triage device is a software workflow tool designed to aid the clinical assessment of adult non-contrast head CT cases with features suggestive of intracranial hemorrhage in the medical care environment.
Product Code	QAS
Body Area	Head
Modality	CT
Predicate Device	Accipiolx (K182177)
Product Performance	None
Clinical Validation	The performance of the HealthICH device has been validated in retrospective stand-alone performance study that was carried out in a simulated synthetics work-flow consisting of truthed validation data. The data included a retrospective cohort of 427 anonymized head CT cases from USE and Israel. The validation set was truthed by two US board certified neuro-radiologists. The stand-alone detection accuracy was measured on this cohort respective to ground truth. The triage effectiveness was evaluated by the standalone per-case processing time of the device. The HeatlhICH triage time (per-case "processing time") was reported as an average 48.67 seconds. HealthICH triage sensitivity is 94.74% and specificity is 92.54%.
Related Use Cases	None

FDA cleared 6/13/2019

HealthMammo

Zebra Medical Vision Ltd.

Indications for Use	The Zebra HealthMammo is a passive notification for prioritization-only, parallel-workflow software tool used by MQSA-qualified interpreting physicians to prioritize patients with suspicious findings in the medical care environment. HealthMammo utilizes an artificial intelligence algorithm to analyze 2D FFDM screening mammograms and flags those that are suggestive of the presence of at least one suspicious finding at the exam-level. HealthMammo produces an exam-level output to a PACS/Workstation for flagging the suspicious case and allows worklist prioritization.
Product Code	QFM
Body Area	Breast
Modality	FFDM Mammogram
Predicate Device	cmTriage
Product Performance	The performance of the HealthMammo device has been validated in a performance study for triage of 2D FFDM screening mammogram cases. The data included a retrospective cohort of 835 anonymized 2D FFDM screening mammograms from the USA, UK, and Israel.
Clinical Validation	None
Related Use Cases	Classifying Suspicious Microcalcifications

FDA cleared 7/16/2020

HealthPNX

Zebra Medical Vision Ltd.

Indications for Use	The Zebra Pneumothorax device is a software tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of Pneumothorax in the medical care environment.
Product Code	QFM
Body Area	Chest
Modality	X-Ray
Predicate Device	cmTriage (K183285)
Product Performance	None
Clinical Validation	The performance of the device has been validated in a pivotal performance study consisting of a truthed validation data-set. The data included 588 anonymized chest X-Rays from USA and Israel. The validation data was labeled by ground truth determined by three radiologists. HealthPNX AUC is 98.3%. The sensitivity is 93.15% and specificity is 92.99%.
Related Use Cases	Pneumothorax

FDA cleared 5/6/2019

HealthVCF

Zebra Medical Vision Ltd.

Indications for Use	HealthVCF is a passive notification for prioritization-only, parallel-workflow software tool used by clinicians to prioritize specific patients within the standard-of-care bone health setting for suspected vertebral compression fractures. HealthVCF uses an artificial intelligence algorithm to analyze chest and abdominal CT scans and flags those that are suggestive of the presence of at least one vertebral compression at the exam level. These flags are viewed by the clinician in Bone Health and Fracture Liaison Service programs in the medical setting via a worklist application on their Picture Archiving and Communication System (PACS).
Product Code	QFM
Body Area	Chest, Abdomen
Modality	CT
Predicate Device	cmTriage
Product Performance	Safety and performance of HealthVCF has been evaluated and verified in accordance with software specifications and applicable performance standards through Software Development and Validation and Verification process.
Clinical Validation	The performance of the HealthVCF device has been validated in a performance study for triage of chest and abdominal CT cases. The data included a retrospective cohort of 611 anonymized Chst and abdominal CT cases from the USE and Israel. The validation data set was truthed by three US Board-Certified Radiologists.
Related Use Cases	None

FDA cleared 5/12/2020

Hepatic VCAR

GE Medical Systems, SCS

Indications for Use	Hepatic VCAR is a CT image analysis software package that allows the analysis and visualization of Liver CT data. It is designed for the purpose of assessing liver morphology, including liver lesion, provided the lesion has different CT appearance from surrounding liver tissue; and its change over time through automated tools for liver, liver lobe, liver segments and liver lesion segmentation and measurement.
Product Code	JAK, LLZ
Body Area	Liver
Modality	CT
Predicate Device	Hepatic VCAR
Product Performance	Verification and validation including risk mitigations have been executed with results demonstrating Hepatic VCAR met the design inputs and user needs with no unexpected results or risks. Bench Testing was conducted to compare the output of the two new algorithms with ground truth annotated by qualified experts. A representative set of clinical sample images was assessed by 3 board certified radiologists using 5-point Likert scale.
Clinical Validation	None
Related Use Cases	None

FDA cleared 3/20/2020

IB Neuro

Imaging Biometrics, LLC

Indications for Use	IB Neuro software allows the processing and display of dynamically acquired MR datasets to evaluate image intensity variations over time. It performs quality control checks and generates parametric perfusion maps such as rCBV, CBF, MTT, and TTP and sends the maps to a PACS for subsequent viewing.
Product Code	LNH
Body Area	Brain
Modality	MRI
Predicate Device	BrainSTAT Software Option for GE Signa MR Scanners (K073167)
Product Performance	Performance testing included software validation, verification and testing per FDA's software validation guidance.
Clinical Validation	None
Related Use Cases	None

FDA cleared 5/15/2008

Icobrain

icometrix NV

Indications for Use	Icobrain is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. Icobrain consists of two distinct image processing pipelines: icobrain cross and icobrain long. Icobrain cross is intended to provide volumes from images acquired at a single time point. Icobrain long is intended to provide changes in volumes between two images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different time points.
Product Code	LLZ
Body Area	Brain
Modality	MR
Predicate Device	icobrain (K161148)
Product Performance	To demonstrate the performance of icobrain, endpoints were validated for accuracy and reproducibility. Subjects include healthy subjects, Alzheimer’s disease patients, multiple sclerosis patient, traumatic brain injury patients, and depression patients. In the accuracy experiments, the volumes/volume changes are compared to simulated and/or manually labeled ground truth volumes/volume changes; in the reproducibility experiments, the volumes/volume changes are compared on test-retest image data sets. Experiment encompassed 463 subject datasets in total. Averaged over all experiments, the Pearson correlation coefficient between the compared measurements was .91 and the intraclass correlation coefficient was .89.
Clinical Validation	None
Related Use Cases	None

FDA cleared 3/8/2018

Icobrain-ctp

Icometrix NV

Indications for Use	icobrain ctp provides both analysis and communication capabilities for dynamic imaging datasets that are acquired with CT Perfusion imaging protocols. Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume.
Product Code	LLZ
Body Area	Brain
Modality	CT
Predicate Device	Viz CTP
Product Performance	To demonstrate the performance of icobrain ctp, the measurements are validated for accuracy and reproducibility. Literature review has been performed to set relevant acceptance criteria for each type of experiment. The device was tested on a dataset of clinical CTP scans.
Clinical Validation	None
Related Use Cases	None

FDA cleared 2/28/2020

Imbio CT Lung Density Analysis Software

Imbio LLC

Indications for Use	The Imbio CT Lung Density Analysis Software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. The Imbio CT Lung Density Analysis Software can be used to support the physician in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from CT thoracic datasets
Product Code	JAK
Body Area	Chest
Modality	CT
Predicate Device	VIDA Diagnostics (K083227)
Product Performance	Testing was conducted on device by analyzing CT datasets available upon request from the COPDGene Study and the DIR-Lab. Primary endpoint was Direct predicate comparison for scan processing completion, segmentation, and thresholding. This was done to verify that the software functions according to its specification and to support substantial equivalence.
Clinical Validation	None
Related Use Cases	None

FDA cleared 9/17/2014

InferRead Lung CT.AI

InferRead Lung CT.AI

Indications for Use	InferRead Lung CT.AI is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest on an asymptomatic population.
Product Code	OEB, LLZ
Body Area	Chest
Modality	CT
Predicate Device	ClearRead CT
Product Performance	Software verification and validation testing were conducted.
Clinical Validation	A pivotal reader study which was a retrospective, fully crossed, multi-reader multi case (MRMC) study was conducted to validate the device. A total of 10 board-certified radiologists and a collection of 249 scans were involved in the reader study.
Related Use Cases	Incidental Pulmonary Nodules on CT

FDA cleared 7/2/2020

KOALA

IB Lab GmbH

Indications for Use	The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on PA/AP knee X-ray images.
Product Code	LLZ, JAK
Body Area	Knee
Modality	X-ray
Predicate Device	VMA system version 3.0 (K172327)
Product Performance	None
Clinical Validation	The company performed standalone clinical performance validation on a dataset of images from large longitudinal US study, Osteoarthritis initiative (OAI) study. The dataset contained a total of 6597 radiographs representing 1149 individuals for which ground truth grading for Kellgren Lawrence grades, osteophyte, sclerosis and joint space narrowing grades, was established by three physicians. In summary, performance validation data establish that KOALA is an effective image processing device that provides reliable measurements and accurate indicators for presence/absence of radiographic features relevant for the diagnosis and classification of osteoarthritis.
Related Use Cases	None

FDA cleared 11/5/2019

Koios DS for Breast

Koios Medical, Inc.

Indications for Use	Koios DS for Breast software applies proprietary artificial intelligence and machine learning algorithms to analyze user-identified regions of interest (ROIs) in ultrasound images and returns an assessment of risk along with specific lesion characteristics associated with reporting and BI-RADS classification.
Product Code	POK
Body Area	Breast
Modality	Ultrasound
Predicate Device	QuantX (DEN270022), ClearView cCAD (K161959)
Product Performance	For malignancy risk classification, bench testing was performed to ascertain the degree of concordance with trained interpreting physicians. Ground truth for malignancy risk classification was determined by pathology or 1- year follow-up for cases that were not biopsied. The system was analyzed on 900 lesions from 900 different patients set aside from the system's training data. System performance on the 900 cases reported an AUC of 88.2%. For BI-RADS decriptors, bench testing was performed to ascertain the degree of concordance with trained interpreting physicians. Ground truth for shape and orientation was supplied by three MQSA certified radiologists. The Koios DS was able to achieve overall accuracy that fell within the 95% confidence interval of the radiologists' performance, rendering them statistically equivalent.
Clinical Validation	A Clinical study was executed to determine the effect of Koios DS for Breast on reader performance. The study objective was to determine the impact on reader performance as defined by the AUC when Koios DS for Breast and an ultrasound examination are combined, compared to ultrasound examination alone in patients that present with a soft tissue breast lesion. The study consisted of 15 readers providing analysis on randomized set of 1800 cases.
Related Use Cases	Breast Density Quantification(Partial)

FDA cleared 7/3/2019

LesionQuant

Cor Tech Labs, Inc.

Indications for Use	LesionQuant is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images.
Product Code	LLZ
Body Area	Brain
Modality	MR
Predicate Device	NeuroQuant
Product Performance	LesionQuant performance was evaluated by comparing segmentation accuracy with expert manual segmentations and by measuring segmentation reproducibility between same subject scans. The system yields reproducible results that are well correlated with computer-aided expert manual segmentations.
Clinical Validation	None
Related Use Cases	None

FDA cleared 9/7/2017

MammoScreen

Therapixel

Indications for Use	MammoScreen is intended for use as a concurrent reading aid for interpreting physicians, to help identify findings on screening FFDM acquired with compatible mammography systems and assess their level of suspicion. Output of the device includes marks placed on findings on the mammogram and level of suspicion scores. The findings could be soft tissue lesions or calcifications. The level of suspicion score is expressed at the finding level, for each breast and overall for the mammogram.
Product Code	QDQ
Body Area	Breast
Modality	FFDM
Predicate Device	Transpara
Product Performance	Standalone performance testing of MammoScreen assess the performance of MammoScreen-algorithms in the absence of a clinician and includes mammograms of women. Testing was conducting at the Mammogram-level, Breast-level and Finding-level.
Clinical Validation	Clinical testing was a retrospective multi reader multi case study meant to compare cancer detection performance of radiologists reading with the aid of MammoScreen to the reading results of the same cohort of radiologists without any decision support.
Related Use Cases	Classifying Suspicious Microcalcifications, Breast Lesion Malignancy Evaluation, Breast Density Quantification

FDA cleared 3/25/2020

MEDO ARIA

Medo.AI

Indications for Use	MEDO ARIA is designed to view and quantify ultrasound image data using machine learning techniques to aid trained medical professionals in diagnosis of developmental dysplasia of the hip (DDH). The device is intended to be used on neonates and infants, aged 0-12 months.
Product Code	QIH
Body Area	Hip
Modality	Ultrasound
Predicate Device	QLAB Advanced Quantification Software
Product Performance	Safety and performance of MEDO ARIA have been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing.
Clinical Validation	None
Related Use Cases	No

FDA cleared 6/11/2020

NeuroQuant

CorTech Labs, Inc

Indications for Use	NeuroQuant is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images.
Product Code	LLZ
Body Area	Brain
Modality	MR
Predicate Device	NeuroQuant
Product Performance	NeuroQuant performance was evaluated by comparing segmentation accuracy with expert manual segmentations and by measuring segmentation reproducibility between same subject scans. The system yields reproducible results that are well correlated with computer-aided expert manual segmentations.
Clinical Validation	None
Related Use Cases	None

FDA cleared 9/7/2017

NinesAI

Nines, Inc.

Indications for Use	NinesAI is a parallel workflow tool indicated for use by hospital networks and trained clinicians to identify images of specific patients to a radiologist, independent of standard of care workflow, to aid in prioritizing and performing the radiological review. NinesAI uses artificial intelligence algorithms to analyze head CT images for findings suggestive of a pre-specified emergent clinical condition.
Product Code	QAS
Body Area	Head
Modality	CT
Predicate Device	BriefCase
Product Performance	Nines performed software verification and validation testing that covers the performance of the algorithms, as well as the performance of the software and its components.
Clinical Validation	The NinesAI device underwent performance testing to verify the efficacy and safety of the machine learning algorithms. Both of the algorithms used in NinesAI were evaluated independently from each other to allow for an individual understand of each algorithm's respective performance.
Related Use Cases	None

FDA cleared 4/21/2020

OsteoDetect

Imagen Technologies

Indications for Use	OsteoDetect analyzes wrist radiographs using machine learning techniques to identify and highlight distal radius fractures during the review of PA and LAT radiographs of adult wrists.
Product Code	QBS
Body Area	Wrist
Modality	Radiograph
Predicate Device	None
Product Performance	Imagen designed and executed a standalone performance assessment. The study data population is an independent dataset not used for model development, consisting of 1000 images (500 PA, 500 LAT) which were randomly sampled from an existing validation databases. Images collected from November 2016-April 2017. Ground truth for each case was determined by three US board certified orthopedic hand surgeons. Ground truth for the presence/absence of distal radius fracture is defined as the majority opinion of at least 2 of 3 clinicians participating. For detection accuracy, the AUC of the ROC is .965, sensitivity is 92.1% and specificity is 90.2%. This performance was observed for both PA and LAT views across elderly status and post-surgical status, and it was observed on radiographs representative of OsteoDetect’s intended use.
Clinical Validation	Imagen performed a MRMC retrospective study to assess performance of OsteoDetect when used with concurrent reading to assist clinicians in detecting distal radius fractures during interpretation of PA and LAT radiographs of adult wrists. 24 Readers evaluated 200 OstoDetect-Aided and 200 OsteoDetect-unaided. The AUC for OsteoDetect-Aided is .889, sensitivity .803, and specificity: .914. OsteoDetect-Unaided AUC .840, sensitivity .747, and specificity .889.
Related Use Cases	None

FDA cleared 5/24/2018

PowerLook Tomo Detection V2 Software

iCAD Inc.

Indications for Use	PowerLook® Tomo Detection V2 Software is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while reading digital breast tomosynthesis (DBT) exams from compatible DBT systems. The system detects soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in the 3D DBT slices.
Product Code	QDQ
Body Area	Breast
Modality	Digital Breast Tomosynthesis
Predicate Device	OsteoDetect (DEN180005)
Product Performance	Verified and validated according to iCAD's design control processes. Verification activity included unit, integration, and system level testing. Validation testing included standalone testing and performing a pivotal reader study to compare the clinical performance of radiologists using CAD detections and Certainty of Finding and Case Scores from the system to that of radiologists using DBT without CAD. A standalone study which evaluated the performance of PLTD without a radiologist was conducted with a sample of 655 Hologic DBT cases. Results show that Case-level sensitivity, lesion-level sensitivity, FP rate in non-cancer cases, and specificity met design specifications. A GE DBT standalone study was conducted to evaluate the performance of PLTD V2 with a sample of 610 GE DBT cases. The purpose of the standalone study was to assess the standalone performance of PLTD V2 on a screening population. Results from the standalone study showed that Case-level sensitivity, lesion-level sensitivity, FP Rate in Non-Cancer Cases, and specificity met design specifications.
Clinical Validation	A pivotal reader study was conducted with 24 tomosynthesis radiologist readers and an enriched sample of 260 Hologic digital breast tomosynthesis (DBT) cases. The purpose of the study was to compare clinical performance of radiologists using CAD detections and Certainty of Find and Case Scores from the PLTD V@ CAD system with DBT images to that of radiologists using DBT without CAD.
Related Use Cases	None

FDA cleared 12/6/2018

ProFound AI Software V2.1

iCAD, Inc.

Indications for Use	ProFound™ AI V2.1 Software is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while reading digital breast tomosynthesis (DBT) exams from compatible DBT systems. The system detects soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in the 3D DBT slices. The detections and Certainty of Finding and Case Scores assist interpreting physicians in identifying soft tissue densities and calcifications that may be confirmed or dismissed by the interpreting physician.
Product Code	QDQ
Body Area	Breast
Modality	Digital Breast Tomosynthesis
Predicate Device	PowerLook Tomo Detection
Product Performance	ProFound AI V2.1 has been verified and validated according to iCAD's design control processes. iCAD performed various standalone testing for the device.
Clinical Validation	None
Related Use Cases	Classifying Suspicious Microcalcifications, Breast Lesion Malignancy Evaluation, Breast Density Quantification

FDA cleared 10/4/2019

qER

Qure.ai Technologies

Indications for Use	qER is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT images. The device is intended to assist hospital networks and trained medical specialists in workflow triage by flagging the following suspected positive findings of pathologies in head CT images: intracranial hemorrhage, mass effect, midline shift and cranial fracture. qER uses an artificial intelligence algorithm to analyze images on a standalone cloud-based application in parallel to the ongoing standard of care image interpretation.
Product Code	QAS
Body Area	Head
Modality	CT
Predicate Device	BriefCase for ICH
Product Performance	None
Clinical Validation	A retrospective, multicenter, blinded clinical study was conducted to test the accuracy of qER at triaging head CT scans containing one of the conditions listed below and to establish the clinical benefit of such triage.
Related Use Cases	Midline Shift

FDA cleared 6/17/2020

Quantib Brain

Quantib B.V.

Indications for Use	Quantib™ Brain is a non-invasive medical imaging processing application that is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures from a set of magnetic resonance (MR) images. The Quantib™ Brain output consists of segmentations, visualizations and volumetric measurements of grey matter (GM), white matter (WM), and cerebrospinal fluid (CSF). The output also visualizes and quantifies white matter hyper intensity (WMH) candidates.
Product Code	LLZ
Body Area	Brain
Modality	MR
Predicate Device	Quantib™ Brain 1.2 ( K163013 )
Product Performance	To validate the quality of Quantib Brain volume measurements and segmentations, the relative volumes and the segmentations were compared to relative volumes derived from manual segmentations and to manual segmentations of the same scan. This analysis was performed for GM, WM, CSF, ICV, and WMHs. For Brain Volumetry, the test set included 33 3DT1w MR images. The set was carefully selected to include data from multiple vendors and a series of representative scan settings. For each scan, 6 slices were selected for comparison.
Clinical Validation	None
Related Use Cases	None

FDA cleared 3/9/2018

Quantib ND

Quantib BV

Indications for Use	Quantib ND is a non-invasive medical imaging processing application that is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures from a set of MR images. The Quantib ND output consists of segmentations, visualizations and volumetric measurements of brain structures and white matter hyper intensities. Quantib ND is a software application on top of Myrian.
Product Code	LLZ
Body Area	Brain
Modality	MR
Predicate Device	Quantib Brain 1.3
Product Performance	To validate the quality of Quantib ND volume measurements and segmentations, these were compared to manual segmentations of the same scan and their derived volumes. For brain tissues, the test set included 33 MR images which was carefully selected to include data from multiple vendors and a series of representative scan settings. The test set for the white matter hyperintensitiy analysis included 45 3D T1w images.
Clinical Validation	None
Related Use Cases	None

FDA cleared 12/27/2018

QuantX

Quantitative Insights, Inc

Indications for Use	QuantX is a computer-aided diagnosis (CADx) software device used to assist radiologists in the assessment and characterization of breast abnormalities using MR image data. The software automatically registers images, and segments and analyzes user-selected regions of interest (ROI).
Product Code	POK
Body Area	Breast
Modality	MR
Predicate Device	None
Product Performance	Standalone testing was performed on cases that were collected over a 7-year span. Dataset included a total of 652 lesions, 314 benign, and 338 malignant. The endpoint was to calculate the QI score of distinguishing between the benign and malignant cases. Overall AUC performance based on the bootstrap method was 0.86.
Clinical Validation	A MRMC was used to determining the impact on reader performance in diagnosing breast cancer. A total of 19 readers completed the study 111 breast MR images.
Related Use Cases	None

FDA cleared 7/19/2017

Rapid ASPECTS

iSchema View Inc.

Indications for Use	Rapid ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data. The Software automatically registers images and segments and analyzes ASPECTS Regions of lnterest (ROIs).
Product Code	POK
Body Area	Head
Modality	CT
Predicate Device	QuantX
Product Performance	iSchema View conducted extensive performance validation testing and software verification and validation testing of the Rapid ASPECTS module both as standalone software and as integrated within the Rapid Platform.
Clinical Validation	The reader study design was a concurrent read, cross-over study design with 50 cases with each of 10 regions scored independently.
Related Use Cases	None

FDA cleared 6/26/2020

RAPID ICH

iSchemaView Inc.

Indications for Use	RAPID ICH is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images.
Product Code	QAS
Body Area	Head
Modality	CT
Predicate Device	BriefCase
Product Performance	Verification, Validation and Standalone Performance Testing was completed
Clinical Validation	iSchemaView conducted a retrospective, blinded, multicenter, multinational study with the RAPID ICH software with the primary endpoint to evaluate the software's performance in identifying noncontrast CT head images containing ICH findings in 336 cases from US and OUS sites.
Related Use Cases	None

FDA cleared 3/28/2020

Rapid LVO 1.0

iSchemaView Inc.

Indications for Use	Rapid LVO is a radiological computer aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive Large Vessel Occlusion (LVO) findings in head CTA images. Rapid LVO uses a software algorithm to analyze images and highlight cases with suspected LVO on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation.
Product Code	QAS
Body Area	Head
Modality	CTA
Predicate Device	Rapid ICH
Product Performance	Verification, validation, and standalone performance testing was completed
Clinical Validation	None
Related Use Cases	None

FDA cleared 7/9/2020

red dot Device

Behold.AI Technologies Limited

Indications for Use	The red dot software platform is a software workflow tool designed to aid the clinical assessment of adult chest X-Ray cases with features suggestive of Pneumothorax in the medical care environment. Red dot analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. red dot is not intended to direct attention to specific portions basis for clinical decision-making nor is it intended to rule out Pneumothorax or otherwise preclude clinical assessment of X-Ray cases.
Product Code	QFM
Body Area	Chest
Modality	X-Ray
Predicate Device	HealthPNX
Product Performance	None
Clinical Validation	Multi-center retrospective anonymized study of adult patient CXR images was performed. The final standalone dataset was composed of 888 CXR images from 2 clinical sites from the US and 2 clinical sites from the UK.
Related Use Cases	Pneumothorax

FDA cleared 2/28/2020

RSI-MRI+

HealthLytix

Indications for Use	RSI-MRI+ is indicated for use as automatic post-acquisition image processing software for analysis of diffusion-weighted and anatomical magnetic resonance imaging data. It is intended for automatic fusion of derived diffusion-weighted MRI data with anatomical T2-weighted MR images. It is additionally intended to provide automatic prostate segmentation, quantification, and reporting of derived image metrics.
Product Code	LLZ
Body Area	Male Pelvis
Modality	DWI-MRI
Predicate Device	Eigen ProFuse CAD (K173744)
Product Performance	Performance testing included protocols demonstrating: Increased conspicuity of the RSI-MRI+ restricted signal map to standard DWI maps in regions of restricted diffusion Accuracy of automated segmentation compared to manual radiologist segmentations Diffusion signal normalization across acquisitions and scanners retrospective Clinical data (including professionally labeled regions-of-interest, T2- weighted anatomical data, and raw diffusion image series) were used for verification and validation of the diffusion analysis (diffusion signal normalization and restricted signal map conspicuity)
Clinical Validation	None
Related Use Cases	None

FDA cleared 11/19/2019

StoneChecker

Imaging Biometrics

Indications for Use	StoneChecker is a standalone post-processing software application which assists trained professionals in evaluating DICOM computer tomography image studies of patients diagnosed with kidney stones.
Product Code	LLZ
Body Area	Abdomen
Modality	CT
Predicate Device	IQQA-BodyImaging Software (K141745)
Product Performance	None
Clinical Validation	StoneChecker underwent usage validation at two clinical sites in Oxford, UK and Beijing, China. The purpose of the testing was to have physicians use StoneChecker to analyze KUB CT scans, validate major functionalities provided by StoneChecker, and provide feedback on the clinical usability of StoneChecker.
Related Use Cases	None

FDA cleared 9/26/2019

SubtleMR

Subtle Medical, Inc.

Indications for Use	SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head, spine, neck and knee MRI, or increase image sharpness for non-contrast enhanced head MRI.
Product Code	LLZ
Body Area	Head, Spine, Neck, Knee
Modality	MRI
Predicate Device	ZOOM (K172768)
Product Performance	None
Clinical Validation	The main performance study, utilizing retrospective clinical data, was divided into two tests; Noise reduction performance test and sharpness increase performance test.
Related Use Cases	None

FDA cleared 9/16/2019

SubtlePET

Subtle Medical, Inc.

Indications for Use	SubtlePET is an image processing software intended for use by radiologists and nuclear medicine physicians for transfer, storage, and noise reduction of FDG and amyloid PET images (including PET/CT and PET/MRI)
Product Code	LLZ
Body Area	All
Modality	FDG, PET,PET/CT, PET/MR
Predicate Device	Sapheneia Clarity(K063391
Product Performance	The following non-clinical performance tests were performed: Design traceability conforming all requirement tracing is complete from design inputs and verification/validation and that all risk controls are implemented. Design verification testing which included confirming all labeling complies with 21CFR801 and all software requirements work as expected. Design validation testing simulated intended use to confirm that the end-to-end functionality of the Subtle PET DICOM Dispatcher in conjunction with the SubtlePET algorithm meets the design requirements. Noise reduction bench testing utilizing representative cases of human data showed increase in quantitative metrics for all cases demonstrating software reduced noise in PET scans.
Clinical Validation	None
Related Use Cases	None

FDA cleared 11/30/2018

Syngo CT CaScoring

Siemens Medical Solutions USA, Inc.

Indications for Use	Image analysis software designed to support the physician in evaluating and documenting calcified coronary lesions, using standard or low-dose spiral or sequential CT scanning data sets. Software can be used to mark calcified coronary lesions and allocate each lesion to one of several coronary arteries. Software also calculates Agatston equivalent score, mass score and volume score of each coronary artery, as well as the corresponding total scores across all coronary arteries.
Product Code	JAK
Body Area	Heart
Modality	CT
Predicate Device	syngo.CT CaScoring
Product Performance	Software validations, bench testing, and clinical data-based software validations have been conducted to the performance claims as well as the claim of substantial equivalence to the predicate devices.
Clinical Validation	Cardiac-gated, non-contrast routine calcium scoring CT data sets were collected from a state-of-the-art CT system at a single center. The amount of calcium in the data covered all ranges of coronary calcification with Agatston scores from 0 to >2000. All data sets were annotated and scored by readers independently with an additional majority vote consensus score. Algorithm performance yielded good comparability to reader study results and met all prespecified acceptability thresholds.
Related Use Cases	Coronary Calcium Detection

FDA cleared 5/14/2020

Syngo CT Lung CAD

Siemens Healthcare GmbH

Indications for Use	The syngo.CT Lung CAD (VC30) is a CAD tool designed to assist radiologists in the detection of solid pulmonary nodules during review of multi-detector computed tomography examinations of the chest.
Product Code	OEB
Body Area	Chest
Modality	CT
Predicate Device	syngo.CT Lung CAD
Product Performance	Standalone performance testing was conducted.
Clinical Validation	None
Related Use Cases	None

FDA cleared 3/9/2020

Transpara

ScreenPoint Medical B.V.

Indications for Use	Transpara software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes locations of calcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam score indicating the likelihood that cancer is present in the exam.
Product Code	QDQ
Body Area	Breast
Modality	FFDM, DBT
Predicate Device	Transpara 1.3.0
Product Performance	Standalone performance testing was conducted.
Clinical Validation	A pivotal reader study was conducted. This study was designed to provide evidence for safety and effectiveness of the device. The objective of the reader study was to determine whether the performance of radiologists detecting breast cancer in DBT exams increases when they concurrently use Transpara compared to when they read DBT exams unaided.
Related Use Cases	Breast Lesion Malignancy Evaluation

FDA cleared 3/5/2020

VIDA vision

VIDA Diagnostics Inc.

Indications for Use	The VIDA\|vision software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. VIDA\|vision can be used to support the physician in the diagnosis and documentation of pulmonary tissue images from CT thoracic datasets. 3-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, low density cluster analysis.
Product Code	JAK
Body Area	Chest
Modality	CT
Predicate Device	VIDA Pulmonary Workstation 2 (PW2)
Product Performance	Verification, validation, and standalone performance testing was completed
Clinical Validation	Evaluate the software’s performance in identifying Contrast-enhanced chest CTs (but not dedicated CTPA protocol), containing Incidental Pulmonary Embolism in 268 cases from 2 clinical study sites in the US. There were 74 positive cases and 194 negative cases (images with iPE versus without iPE) included in the analysis.
Related Use Cases	None

FDA cleared 08/07/2020

Vitrea CT Brain Perfusion

Vital Images, Inc.

Indications for Use	Vitrea CT Brain Perfusion is a noninvasive post-processing software that calculates cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e., delay of tissue response, time to peak), and mean transit time (MTT) from dynamic CT image data. It displays time density curves, perfusion characteristics in perfusion and summary maps, as well as regions of interest and mirrored regions.
Product Code	LLZ
Body Area	Brain
Modality	CT
Predicate Device	Vitrea CT Brain Perfusion software (K121213)
Product Performance	Algorithm testing was performed to validate the proper function of the Bayesian algorithms. The test passed all the verification and validation and is therefore considered validated and acceptable. External validation evaluated if the Brain Perfusion with Bayesian algorithm (subject device) was substantially equivalent with the Brain Perfusion with SVD+ algorithm (predicate device). Based on the scores provided by the physicians, Vital concluded the Brain Perfusion with Bayesian algorithm is as safe and effective as the already cleared Brain Perfusion with SVD+ algorithm and fulfills its intended use.
Clinical Validation	None
Related Use Cases	None

FDA cleared 11/20/2018

Vitrea CT Lung Density Analysis Software

Vital Images, Inc.

Indications for Use	Vitrea CT Lung Density Analysis assists in analyzing lung densities and volumes. It semi automatically segments lung tissues with quantifiable controls and renderings to aid communication with the pulmonologist.
Product Code	JAK
Body Area	Chest
Modality	CT
Predicate Device	VIDA Pulmonary Workstation 2 (PW2) (K083227)
Product Performance	The Vitrea CT Lung Density Analysis software was designed, developed, and tested according to written procedures that included risk management. Software testing was completed to ensure the new features operate according to defined requirements. The following design control measures were applied to the development of the Vitrea CT Lung. During external validation of the CT Lung Density Analysis software, experienced users evaluated the visualization, axial plane location, quantification of density, and snapshots among other features. Each user felt that the Vitrea CT Lung Density Analysis software enables the user to assess and quantify lung density.
Clinical Validation	None
Related Use Cases	None

FDA cleared 10/10/2015

Viz CTP

Viz.ai, Inc.

Indications for Use	Viz CTP is a standalone software package that is comprised of several modules including DICOM receiving and sending modules, a study processor, image analysis algorithm, as well as software system components including a DICOM storage database and system health-monitoring. The device is designed to automatically receive, identify, extract, and analyze a CTP study of the head embedded in DICOM image data. The software outputs parametric maps related to tissue blood flow (perfusion) and tissue blood volume that are written back to the source DICOM.
Product Code	LLZ
Body Area	Brain
Modality	CT
Predicate Device	iSchemaView RAPID
Product Performance	Viz.ai Inc. performed software verification and validation testing of the device and additional performance testing on a commercially available simulated dataset (digital phantom) generated by simulating tracer kinetic theory, and includes a wide range of clinically relevant values of perfusion parameters as ground truth.Correlations between the output of the Viz CTP device and the ground truth values were calculated, and compared to published correlations between the ground truth and the outputs of 7 other commercially available and academic CTP post-processing software. The results of performance testing showed that the Viz CTP device achieved the pre-established performance goals for AIF detection, soft matter extraction, and each perfusion parameter: cerebral blood flow (CBF), cerebral blood volume (CBV), mean transit time (MTT), and time to maximum residue (TMax).
Clinical Validation	None
Related Use Cases	None

FDA cleared 4/20/2018

Viz ICH

Viz.ai, Inc

Indications for Use	Viz ICH is a notification-only, parallel workflow tool. Viz ICH uses an artificial intelligence algorithm to analyze non-contrast CT images of the brain acquired in the acute setting, and sends notifications to a neurovascular or neurosurgical specialist that a suspected intracranial hemorrhage has been identified and recommends review of those images.
Product Code	QAS
Body Area	Brain
Modality	CT
Predicate Device	ContaCT, BriefCase
Product Performance	Viz.ai conducted a retrospective study assess the standalone performance of the image analysis algorithm and notification functionally of Viz ICH. The study evaluated the Viz ICH image analysis algorithm in terms of sensitivity and specificity with respect to a ground truth, as established by trained neuro-radiologists, in the detection of ICH in the brain.
Clinical Validation	None
Related Use Cases	None

FDA cleared 3/18/2020

Indications for Use	AccipioIx is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial hemorrhage in the acute care environment. AccipioIx analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage.
Product Code	QAS
Body Area	Head
Modality	CT
Predicate Device	Accipiolx
Product Performance	Verification, Validation and Performance Testing was completed
Clinical Validation	MaxQ-AI conducted a retrospective study to test the clinical performance of Accipiolx in processing non-contrast head CT cases with a high or low probability of ICH. Analysis of 360 newly tested cases collected from multiple sites across 17 US states.
Related Use Cases	None

Indications for Use	ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart for use on individual patients with cardiovascular disease.
Product Code	LLZ
Body Area	Heart
Modality	MR,CT
Predicate Device	Mr-CT VVA
Product Performance	The device has been designed, developed, tested, verified and validated according to documented procedures and specific protocols in line with the FDA guidance documents. It was tested and validated with synthetic and phantom data.
Clinical Validation	None
Related Use Cases	None