The tool is used for detecting OSA in awake patients; it can precisely scan upper airway and analyze the gap between normal breathing and Müller Maneuver models |
K180867 |
Radiology |
December 2018 |
AmCAD-US
(AmCad BioMed Corporation, Taipei City, Taiwan) |
AI |
The tool is used to view and quantify ultrasound image data of backscattered signals acquired from ultrasound data |
K162574 |
Radiology |
May 2017 |
AmCAD-UT Detection 2.2
(AmCad BioMed Corporation, Taipei City, Taiwan) |
AI |
The software is used for facilitating the detection, visualization, and characterization of thyroid nodule features on sonographic images |
K180006 |
Radiology |
August 2018 |
AmCAD-UV
(AmCad BioMed Corporation, Taipei City, Taiwan) |
AI |
The tool is used for classifying the ultrasonic color intensity data from signals of flow Doppler ultrasound images |
K170069 |
Radiology |
April 2017 |
Arterys Cardio DL
(Arterys Inc., San Francisco, CA, USA) |
DL |
The software is used for the analysis of cardiac MRI images |
K163253 |
Radiology
Cardiology |
January 2017 |
Arterys Oncology DL
(Arterys Inc., San Francisco, CA, USA) |
DL |
The software is used for measuring and tracking lesions and nodules from MRI and CT images |
K173542 |
Radiology
Oncology |
January 2018 |
Arterys MICA
(Arterys Inc., San Francisco, CA, USA) |
AI |
AI platform used for liver and lung cancer diagnosis from MRI and CT images |
K182034 |
Radiology
Oncology |
October 2018 |
BladderScan Prime PLUS System
(Verathon Inc., Bothell, WA, USA) |
DL |
The tool provides improved bladder volume measurement accuracy |
K172356 |
Radiology |
Sepember 2017 |
Bone VCAR (BVCAR)
(GE Medical Systems SCS, Buc, France) |
DL |
The tool is used for automated spine labeling (segments or whole spine) from CT images |
K183204 |
Radiology |
April 2019 |
Brainomix 360° e-CTA
(Brainomix Limited, Oxford, UK) |
AI |
The tool is used for automatically detecting LVO on CT angiography |
K192692 |
Radiology |
May 2020 |
BriefCase
(Aidoc Medical, Ltd., Tel Aviv, Israel) |
DL |
The tool is used for detecting acute abnormalities across the body, helping radiologists to prioritize life-threatening cases, expediting patient care |
K180647 |
Radiology
Emergency Medicine |
August 2018
|
cvi42 for cardiac CT/MRI
(Circle Cardiovascular Imaging Inc., Calgary, AB, Canada) |
ML/DL |
The software is used for assessing heart function, flow, and tissue attributes from CT/MRI images |
K141480 |
Radiology
Cardiology |
August 2014 |
ClariCT.AI
(ClariPI Inc., Seoul, South-Korea) |
DL |
The tool is used for processing and enhancing CT images reducing noise |
K183460 |
Radiology |
Jun2019 |
ClearRead CT
(Riverain Technologies, LLC, Miamisburg, OH, USA) |
DL |
The software is used to detect pulmonary nodules and abnormalities in CT |
K161201 |
Radiology
Oncology |
September 2016 |
cmTriage
(CureMetrix, Inc., La Jolla, CA, USA) |
AI |
cmTriage is a tool enabling radiologists to triage, sort, and prioritize mammography |
K183285 |
Radiology
Oncology |
March 2019
|
ContaCT
(Viz.AI, San Francisco, CA, USA) |
AI |
The software is used for detecting stroke from CT angiogram images of the brain |
DEN170073 |
Radiology
Neurology |
February 2018 |
Critical Care Suite
(GE Medical Systems, LLC, Waukesha, WI, USA) |
AI |
The platform is used for automatically detecting PNX from X-rays, triaging critical cases |
K183182 |
Radiology Emergency Medicine |
August 2019 |
CuraRad-ICH
(CuraCloud Corp., Seattle, WA, USA) |
DL |
The tool is used for triaging suspected intracranial hemorrhage |
K192167 |
Radiology |
April 2020 |
Deep Learning Image Reconstruction
(GE Medical Systems, LLC, Waukesha, WI, USA) |
DL |
The application is used for CT image reconstruction
Follow-up—K201745 DL Image Reconstruction for Gemstone Spectral Imaging (December 2020) |
K183202 |
Radiology |
April 2019 |
DV.Target
(Deepvoxel Inc., Irvine, CA, USA) |
DL |
The algorithm is used to automatically delineate OARs. Contours generated by DV.Target may be used as an input to clinical workflows in radiation therapy. |
K202928 |
Radiology |
April 2021 |
EchoMD Automated Ejection Fraction Software
(Bay Labs, Inc., San Francisco, CA, USA) |
ML |
This software is used for automated ECG analysis |
K173780 |
Radiology
Cardiology |
June 2018 |
FerriSmart Analysis System
(Resonance Health Analysis Service Pty Ltd., Burswood, Australia) |
ML/CNN |
The software is used for measuring liver iron concentration from R2-MRI images. The system is based on the previously approved (K043271, Jan2005) R2-MRI Analysis System |
K182218 |
Radiology
Internal Medicine |
November 2018 |
HealthCXR
(Zebra Medical Vision Ltd., HaMerkaz, Israel) |
AI |
The software is used for identifying and triaging pleural effusion in chest X-rays |
K192320 |
Radiology
Emergency Medicine |
November 2019 |
HealthMammo
(Zebra Medical Vision Ltd., HaMerkaz, Israel) |
DL |
The tool is used for supporting identifying and prioritizing suspicious mammograms |
K200905 |
Radiology
Oncology |
June 2020 |
HealthPNX
(Zebra Medical Vision Ltd., HaMerkaz, Israel) |
AI |
The tool increases the radiologist’s confidence in making PNX diagnosis from chest X-rays imaging output |
K190362 |
Radiology
Emergency Medicine |
May 2019 |
icobrain
(icometrix NV, Leuven, Belgium) |
ML and DL |
The software is used for interpreting MRI images from the brain for detecting neurological disorders |
K181939 |
Radiology
Neurology |
November 2018 |
Illumeo System
(Philips Medical Systems Technologies, Ltd., Haifa, Israel) |
AI |
The tool is used for acquiring, storing, distributing, processing, and displaying images |
K173588 |
Radiology |
January 2018 |
lnferRead Lung CT
(Beijing Infervision Technology Co. Ltd., Beijing, China) |
AI |
The tool is used for assisting radiologists fin detecting pulmonary nodules from CT
(NCT04119960) |
K192880 |
Radiology
Oncology |
June 2020 |
Infinitt PACS 7.0
(Infinitt Healthcare Co. Ltd., Seoul, South-Korea) |
AI |
The software is used to analyze incoming tasks, identifying high-priority cases |
K172803 |
Radiology |
Sepember 2017 |
KOALA
(IB Lab GmbH, Wien, Austria) |
DL |
The algorithm is used to detect radiographic signs of knee osteoarthritis |
K192109 |
Radiology |
November 2019 |
Koios DS for Breast
(Koios Medical, Inc., Chicago, IL, USA) |
AI |
The software is used for analyzing ultrasound images for providing improved accuracy and efficiency in cancer diagnosis |
K190442 |
Radiology
Oncology |
July 2019 |
LiverMultiScan
(Perspectum Diagnostics Ltd., Oxford, UK) |
ML |
This platform is used to assess liver tissue to enable diagnostic and patient management decisions. |
K190017 |
Radiology |
June 2019 |
LVivo Software Application
(DiA Imaging Analysis Ltd., Beer-Sheva, Israel) |
AI |
The software provides an automated AI-based ejection fraction analysis, allowing a fast assessment of cardiac functions |
K210053 |
Radiology |
January 2021 |
LungQ
(Thirona Corp., Nijmegen, Netherlands) |
AI |
The software is used for automatically identifying lung abnormalities from CT images |
K173821 |
Radiology |
June 2018 |
MRCP+ V1.0
(Perspectum Diagnostics Ltd., Oxford, UK) |
AI |
The software is used for quantitatively analyzing the biliary tree and pancreatic duct from MRCP images |
K183133 |
Radiology |
January 2019 |
MRCAT brain
(Philips Medical Systems MR, Vantaa, Finland) |
AI |
The tool is used for radiotherapy planning of primary and metastatic tumors using MRI |
K193109 |
Radiology |
January 2020 |
OsteoDetect
(Imagen Technologies, Inc., New York, NY, USA) |
DL |
The software is used for detecting signs of distal radius fracture from X-ray |
DEN180005 |
Radiology
Emergency Medicine |
May 2018 |
PixelShine
(ALGOMEDICA, Palo Alto, CA, USA) |
DL |
The software is used for improving the quality of scans obtained from any CT images, reducing noise |
K161625 |
Radiology |
September 2016 |
PowerLook Density Assessment Software
(iCAD, Inc., Nashua, NH, USA) |
ML |
The algorithm is used for assessing breast density in 2D and 3D mammography |
K180125 |
Radiology |
April 2018 |
ProFound™ AI Software
(iCAD, Inc., Nashua, NH, USA) |
DL |
The software is used for detecting both malignant soft tissue densities and calcifications from DBT images |
K191994 |
Radiology
Oncology |
April 2019 |
QuantX
(Qlarity Imaging, Chicago, IL, USA) |
AI |
The software is used for assessing and characterizing breast abnormalities from MRIdata |
DEN170022 |
Radiology
Oncology |
July 2017 |
qp-Prostate
(Quibim S.L., Valencia, Spain) |
AI |
The tool is used for analyzing prostate MRI images |
K203582 |
Radiology
Oncology |
December 2020 |
Rapid ASPECTS
(iSchemaView, Inc., San Mateo, CA, USA) |
AI |
The tool is used as assisted diagnostic software for lesions suspicious of cancer |
K200760 |
Radiology |
May 2020 |
RAPID-ICH
(iSchemaView, Inc., San Mateo, CA, USA) |
AI |
The tool is used to triage non-contrast CT (NCCT) cases for rapidly detecting suspicious intracranial hemorrhage |
K193087 |
Radiology |
March 2020 |
RayCare 3.1
(RaySearch Laboratories AB, Stockholm, Sweden) |
ML/DL |
The software is used for improving workflow efficiency across different treatments in medical, radiation, and surgical oncology to support decisions in the clinic |
K200487 |
Radiology
Oncology |
June 2020 |
RayStation 10.1
(RaySearch Laboratories AB, Stockholm, Sweden) |
ML |
The platform is used to automatically generate treatment plans |
K210645 |
Radiology
Oncology |
June 2021 |
RBknee
(Radiobotics ApS, Copenaghen, Denmark) |
ML |
The software is used for automatically identifying osteoarthritis in the knees based on X-ray images |
K203696 |
Radiology |
August 2021 |
Red DotTM
(Behold.AI Technologies Ltd., London, UK) |
AI |
The software is used for assessing PNX from chest X-ray images |
K191556 |
Radiology |
January 2020 |
StoneChecker
(Imaging Biometrics, LLC, Elm Grove, WI, USA) |
AI |
The software is used with standard CT scans in people with kidney stones for measuring stone parameters and to inform clinical decisions |
K191530 |
Radiology |
June 2019 |
StrokeViewer
(NiCo-Lab B.V., Amsterdam, Netherlands) |
AI |
This tool is used for the localization and quantification of stroke biomarkers from CT scans |
K200873 |
Radiology |
October 2020 |
SubtleMR
(Subtle Medical, Inc., Menlo Park, CA, USA) |
CNN |
The application is used for improving the quality of MRI images increasing resolution and reducing noise |
K191688 |
Radiology |
September 2019 |
SubtlePET
(Subtle Medical, Inc., Menlo Park, CA, USA) |
DNN |
The application is used for processing PET images |
K182336 |
Radiology |
November 2018 |
syngo.CT Cardiac Planning
(Siemens Medical Solutions USA, Inc., Malvern, PA, USA) |
AI |
The software is used forenhancing CT images; analysis of morphology and pathology of vascular and cardiac structures |
K200515 |
Radiology |
March 2020 |
TransparaTM
(Screenpoint Medical B.V., Nijmegen, Netherlands) |
ML |
The software provides a support solution for mammography, identifying suspicious areas in 2D and 3D mammograms |
K192287 |
Radiology
Oncology |
December 2019 |
Veolity
(MeVis Medical Solutions AG, Bremen, Germany) |
ML |
The software is used to recognize even the subtlest potential signs of lung cancer |
K201501 |
Radiology |
February 2021 |
Workflow Box including DCLExpertTM
(Mirada Medical Ltd., Oxford, UK) |
AI |
The software is used for autocontouring organs for cancer treatment planning |
K181572 |
Radiology |
July 2018 |
AI-ECG Platform
(Shenzhen Carewell Electronics, Ltd., Shenzhen, China) |
AI |
AI platform for assisting physicians in measuring and interpreting ECG |
K180432 |
Cardiology |
November 2018 |
AI-ECG Tracker
(Shenzhen Carewell Electronics, Ltd., Shenzhen, China) |
AI |
The tool is used for improving the detection efficiency of non-persistent arrhythmias (irregular heartbeats) |
K200036 |
Cardiology |
March 2020 |
BioFlux Device
(Biotricity Inc., Redwood City, CA, USA) |
AI |
The tool is used for detecting arrhythmias |
K172311 |
Cardiology |
December 2017 |
EchoGo Core
(Ultromics Ltd., Oxford, UK) |
ML |
The application is used to automatically evaluate cardiac functions from echocardiography, enabling physicians to diagnose heart failure and coronary artery disease |
K191171 |
Cardiology |
November 2019 |
Eko Analysis Software
(Eko Devices Inc., Oakland, CA, USA) |
ANN |
The software is used for detecting suspected murmurs in the heart sounds and atrial fibrillation from ECG data |
K192004 |
Cardiology |
January 2020 |
eMurmur ID
(CSD Labs GmbH, Graz, Austria) |
ML |
The software is used to understand, identify, and detect heart murmurs |
K181988 |
Cardiology |
April 2019 |
KardiaAI
(AliveCor, Inc., Mountain View, CA, USA) |
AI |
The tool is used for enhancing cardiac MRI to improve diagnosis of heart disorders |
K181823 |
Cardiology |
November 2019 |
KOSMOS
(EchoNous Inc., Redmond, WA, USA) |
DL |
This tool combining ultrasound with DL is used for clinical assessment of the heart, lungs, and abdomen |
K193518 |
Cardiology |
March 2020 |
Ventripoint Medical System Plus (VMS+) 3.0
(Ventripoint Diagnostics Ltd., Toronto, ON, Canada) |
AI |
The tool is used for measuring whole heart function using conventional ultrasound
(NCT01557582) |
K191493 |
Cardiology |
October 2019 |
Altoida
(Altoida, Inc., Washington, DC, USA) |
ML |
The software is used for detecting AD up to 10 years prior to the onset. ML is used for classifying patients’ risk of MCI due to AD (NCT02843529) |
FDA-ClassII |
Neurology |
August 2021 |
BrainScope Ahead 100
(Brainscope Company, Inc., Bethesda, MD, USA) |
AI |
The software is used for interpreting the structural condition of the patient’s brain after head injury from EEG data |
DEN140025 |
Neurology |
November 2014 |
Cognoa ASD Diagnosis Aid
(Cognoa, Inc., Palo Alto, CA, USA) |
ML |
The software is used for evaluating patients at risk of ASD |
DEN200069 |
Neurology |
June 2021 |
complete control system gen2
(Coapt, LLC, Chicago, IL, USA) |
AI/ML |
The platform provides a human–bionic interface that learns and adapts to users, giving them unrivaled control of their prosthetic arms |
K191083 |
Neurology |
April 2019 |
EnsoSleep
(EnsoData, Inc., Madison, WI, USA) |
AI |
The application assists clinicians in the diagnosis of sleep disorders |
K162627 |
Neurology |
March 2017 |
QbTest/QbCheck
(QbTech AB, Goteborg, Sweden) |
AI/ML |
The tools are used for braingazing using eye-tracking technology to capture eye vergence and AI algorithms for classifying ADHD patients vs. non-ADHD |
K040894 K143468 |
Neurology
Psychiatry |
June 2004 March 2016 |
Clarus 700
(Carl Zeiss Meditec Inc., Dublin, CA, USA) |
DL |
The algorithm is applied to diagnosing and monitoring retina disorders |
K191194 |
Ophthalmology |
May 2019 |
EyeArt
(EyeNuk, Inc., Woodland Hills, CA, USA) |
AI |
The software is used as a screening tool for detecting diabetic retinopathy |
K200667 |
Ophthalmology |
March 2020 |
IDx
(Digital Diagnostics Inc. -IDx LLC., Coralville, IA, USA) |
AI |