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.

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 -Engine

Siemens Medical Solutions USA, Inc.

Indications for Use	AI-Rad Companion (Engine) is a software platform that provides basic visualization and enables external post-processing extension for medical images used for diagnostic purposes. The software platform is designed to support technicians and trained physicians in qualitative and quantitative measurement and analysis of clinical data. The software platform provides means for storing of data and for transferring data into other systems such as PACS systems. The software platform provides an interface to integrate processing extensions.
Product Code	LLZ, JAK
Body Area	All
Modality	All
Predicate Device	syngo.CT View&GO (K170952)
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 2/1/2019

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 MICA

Arterys Inc.

Indications for Use	Arterys MICA is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data, with the exception of mammography. Also includes an optional Cardio AI module which is used to analyze the heart and its major vessels. It also includes an optional Oncology AI module which provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations.
Product Code	LLZ
Body Area	All
Modality	CT, MR
Predicate Device	Arterys Viewer (K171544) , Arterys Cardio DL (K163253 ), Arterys Oncology DL (K173542)
Product Performance	Safety and performance of Arterys MICA has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Software verification and validation activities were performed in accordance with IEC 62304:2006/AC:2015- Medical device software-Software life cycle processes and ISO 14971:2007 Medical devices-- Application of risk management to medical devices, in addition to the FDA Guidance documents.
Clinical Validation	None
Related Use Cases	None

FDA cleared 10/17/2018

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

Arterys Viewer

Arterys, Inc.

Indications for Use	Arterys Viewer is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The Arterys Viewer displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements.
Product Code	LLZ
Body Area	All
Modality	All
Predicate Device	HealthMyne PACS (K152186)
Product Performance	Safety and performance of Arterys Viewer 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	None

FDA cleared 7/18/2017

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

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

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

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

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

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

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

IDX-DR

IDX, LLC

Indications for Use	IDx-DR is indicated for use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400.
Product Code	PIB
Body Area	Eyes
Modality	FA
Predicate Device	None
Product Performance	None
Clinical Validation	IDx conducted a pivotal study with 900 patients who were enrolled at 10 sites. The primary outcomes were the sensitivity and specificity of IDx-DR. Results from the IDx-DR study resulted in sensitivity to be 87% and specificity to be 90%.
Related Use Cases	None

FDA cleared 4/11/2018

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

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

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 (K061855)
Product Performance	None
Clinical Validation	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.
Related Use Cases	None

FDA cleared 9/7/2017

OstoDetect

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

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

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

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	An image analysis software package for evaluating CT data sets. The software is designed to support the physician in evaluating and documenting calcified coronary lesions using standard or low-dose spiral or sequential CT scanning data sets. The device can be used to interactively mark calcified coronary lesions and to allocate each lesion to one of several coronary arteries. It also calculates the Agatson equivalent score, the mass score and the volume score of each coronary artery as well as the corresponding total scores across all coronary arteries.
Product Code	JAK
Body Area	Heart/Chest
Modality	CT
Predicate Device	Calcium Scoring (K990426), HealthCCS (K172983)
Product Performance	Performance tests were conducted to test the functionality of the syngo.CT CaScoring. These tests have been performed to test the ability of the included features of the subject device. Results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence. For the new feature automated calcium scoring evaluation, a bench test has been conducted to show it performs as intended. The algorithm was successfully executed on all test data. An adequate overall accuracy of the prediction of the calcium risk category was found.
Clinical Validation	None
Related Use Cases	Coronary Calcium Detection

FDA cleared 12/17/2019

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

Indications for Use	Accipiolx 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. Accipiolx analyzes cases using and 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	ContaCt(Viz.AI DEN 170073)
Product Performance	None
Clinical Validation	MaxQ-AI conducted a retrospective study to test the sensitivity and specificity of Accipiolx in processing non-contrast head CT cases with a high or low probability of intracranial hemorrhage (ICH). Device sensitivity and specificity was compared to ground truth established by concurrence of at least two expert neuroradiologst readers. Analysis of 360 cases collected from over 30 US sites demonstrate system sensitivity and specificity of 92% and 86% respectively. The average per-case processing time was 4.1 minutes.
Related Use Cases	None