FDA-approved A.I.-based algorithms

Name of device or algorithm
(Click to sort Ascending)
Name of parent company
(Click to sort Ascending)
Short description
(Click to sort Ascending)
FDA approval number
(Click to sort Ascending)
Type of FDA approval
(Click to sort Ascending)
Mention of A.I. in announcement
(Click to sort Ascending)
If no mention of A.I. in FDA announcement
(Click to sort Ascending)
Date
(Click to sort Ascending)
Medical specialty
(Click to sort Ascending)
Secondary medical specialty
(Click to sort Ascending)
Arterys Cardio DL
Arterys Inc
software analyzing cardiovascular images from MR
K163253
510(k) premarket notification
deep learning
2016 11
Radiology
Cardiology
EnsoSleep
EnsoData, Inc
diagnosis of sleep disorders
K162627
510(k) premarket notification
automated algorithm
2017 03
Neurology
Arterys Oncology DL
Arterys Inc
medical diagnostic application
K173542
510(k) premarket notification
deep learning
2017 11
Radiology
Oncology
Idx
IDx LLC
detection of diabetic retinopathy
DEN180001
de novo pathway
A.I.
2018 01
Ophthalmology
Koios DS for Breast
Koios Medical, Inc
diagnostic software for lesions suspicious for cancer
K190442
510(k) premarket notification
machine learning
2019 06
ContaCT
Viz.AI
stroke detection on CT
DEN170073
de novo pathway
A.I.
2018 02
Radiology
Neurology
OsteoDetect
Imagen Technologies, Inc.
X-ray wrist fracture diagnosis
DEN180005
de novo pathway
deep learning
2018 02
Radiology
Emergency medicine
Guardian Connect System
Medtronic
predicting blood glucose changes
P160007
PMA
A.I.
2018 03
Endocrinology
EchoMD Automated Ejection Fraction Software
Bay Labs, Inc.
echocardiogram analysis
K173780
510(k) premarket notification
machine learning
2018 05
Radiology
Cardiology
DreaMed
DreaMed Diabetes, Ltd
managing Type 1 diabetes.
DEN170043
de novo pathway
A.I.
2018 06
Endocrinology
LungQ
Thirona Corporation
Quantitative analysis of chest CT scans
K173821
PMA
Not available
https://bit.ly/2EkHTCM
2018 06
Radiology
Pulmonology
BriefCase
Aidoc Medical, Ltd.
triage and diagnosis of time sensitive patients
K180647
510(k) premarket notification
deep learning
2018 07
Radiology
Emergency medicine
ProFound™ AI Software V2.1
iCAD, Inc
breast density via mammogprahy
K191994
510(k) premarket notification
deep learning
2018 07
Radiology
Oncology
SubtlePET
Subtle Medical, Inc
radiology image processing software
K182336
510(k) premarket notification
deep neural network-based algorithm
2018 09
Radiology
Arterys MICA
Arterys Inc
Liver and lung cancer diagnosis on CT and MRI
K182034
510(k) premarket notification
A.I.
2018 08
Radiology
Oncology
AI-ECG Platform
Shenzhen Carewell Electronics., Ltd
ECG analysis support
K180432
510(k) premarket notification
AI-ECG
2018 09
Cardiology
Accipiolx
MaxQ-Al Ltd
acute intracranial hemorrhage triage algorithm
K182177
510(k) premarket notification
artificial intelligence algorithm
2018 10
Radiology
Neurology
icobrain
icometrix NV
MRI brain interpretation
K181939
510(k) premarket notification
machine learning and deep learning
2018 10
Radiology
Neurology
FerriSmart Analysis System
Resonance Health Analysis Service Pty Ltd
measure liver iron concentration
K182218
510(k) premarket notification
artificial intelligence
2018 11
Internal Medicine
cmTriage
CureMetrix, Inc.
Mammogram workflow
K183285
510(k) premarket notification
artificial intelligence algorithm
2019 03
Radiology
Oncology
Deep Learning Image Reconstruction
GE Medical Systems, LLC.
CT image reconstruction
K183202
510(k) premarket notification
deep learning
2019 04
Radiology
HealthPNX
Zebra Medical Vision Ltd.
Chest X-Ray assessment pneumothorax
K190362
510(k) premarket notification
artificial intelligence
2019 05
Radiology
Emergency medicine
Advanced Intelligent Clear-IQ Engine (AiCE)
Canon Medical Systems Corporation
Noise reduction algorithm
K183046
510(k) premarket notification
Deep Convolutional Neural Network
2019 06
Radiology
SubtleMR
Subtle Medical, Inc
radiology image processing software
K191688
510(k) premarket notification
convulutional neural network
2019 07
Radiology
AI-Rad Companion (Pulmonary)
Siemens Medical Solutions USA, Inc.
CT image reconstruction - pulmonary
K183271
510(k) premarket notification
deep learning
2019 07
Radiology
Critical Care Suite
GE Medical Systems, LLC.
Chest X-Ray assessment pneumothorax
K183182
510(k) premarket notification
artificial intelligence algorithms
2019 08
Radiology
Emergency medicine
AI-Rad Companion (Cardiovascular)
Siemens Medical Solutions USA, Inc.
CT image reconstruction - cardiovascular
K183268
510(k) premarket notification
deep learning
2019 09
Radiology
EchoGo Core
Ultromics Ltd.
quantification and reporting of results of cardiovascular function
K191171
510(k) premarket notification
machine learning-based algorithms
2019 11
Cardiology
Radiology
TransparaTM
Screenpoint Medical B.V.
Mammogram workflow
K192287
510(k) premarket notification
machine learning components
2019 12
Radiology
Oncology
QuantX
Quantitative Insights, Inc
Radiological software for lesions suspicious for cancer
DEN170022
de novo pathway
artificial intelligence algorithm
2020 01
Radiology
Oncology
Eko Analysis Software
Eko Devices Inc.
Cardiac Monitor
K192004
510(k) premarket notification
artificial neural network
2020 01
Cardiology
BodyGuardian Remote Monitoring System
Preventice
Remote monitoring device for patients with cardiac arrhythmias
K121197
510(k) premarket notification
Not available
https://bit.ly/3czSSF2
2012 08
Cardiology
Temporal Comparison
Riverain Technologies
Chest X-Ray Scanning Software
K123526
510(k) premarket notification
Not available
https://wb.md/2ww0IiD
2012 12
Radiology
Ahead 100
BrainScope
Device to interprete the structural condition of the patient’s brain after head injury.
DEN140025
de novo pathway
Not available
https://bit.ly/2TqDweq
2014 08
Neurology
AliveCor
AliveCor
detection of atrial fibrillation
K140933
510(k) premarket notification
Not available
https://bit.ly/3323d8n
2014 08
Cardiology
QbCheck
QbTech AB
diagnosis and treatment of ADHD
K143468
510(k) premarket notification
Not available
https://bit.ly/39wKdBl
2016 03
Psychiatry
Steth IO
Stratoscientific, Inc.
acoustic device to collect heart and lung sounds
K160016
510(k) premarket notification
Not available
https://stethio.com/ai/
2016 07
General medicine
Cantab Mobile
CAMBRIDGE COGNITION LTD.
memory assessment for the elderly
K161328
510(k) premarket notification
Not available
https://bit.ly/39uIYm7
2017 01
Neurology
Geriatrics
AmCAD-US
AmCad BioMed Corporation
analysis of thyroid nodules
K162574
510(k) premarket notification
Not available
https://bloom.bg/38pWbeR
2017 05
Radiology
Endocrinology
Rooti Rx System ECG Event Recorder, Rooti Link APP Software
Rooti Labs Ltd
wearable continuous ECG monitor
K163694
510(k) premarket notification
Not available
https://bit.ly/3cuSdEO
2017 11
Cardiology
BioFlux
Biotricity Inc.
detecting arrhythmias
K172311
510(k) premarket notification
Not available
https://bit.ly/2VX36t4
2017 12
Cardiology
WAVE Clinical Platform
Excel Medical Electronics, LLC
Monitoring vital signs
K171056
510(k) premarket notification
Not available
https://bit.ly/2Iqfz0C
2018 01
Hospital monitoring
DM-Density
Densitas, Inc.
Breast density via mammogprahy
K170540
510(k) premarket notification
Not available
https://bit.ly/3azmgJU
2018 02
Radiology
NeuralBot
Neural Analytics, Inc.
transcranial Doppler probe positioning
K180455
510(k) premarket notification
Not available
https://bit.ly/2ItFape
2018 04
Radiology
HealthCCS
Zebra Medical Vision Ltd.
coronary artery calcification algorithm
K172983
510(k) premarket notification
Not available
https://bit.ly/2uYRSJE
2018 05
Radiology
Cardiology
MindMotion GO
MindMaze SA
software with rehabilitation exercises for the elderly
K173931
510(k) premarket notification
Not available
https://bit.ly/2wDsvxi
2018 05
Orthopedics
ECG App
Apple, Inc.
detection of atrial fibrillation
DEN180044
de novo pathway
Not available
https://bit.ly/3cB7eFd
2018 08
Cardiology
FibriCheck
Qompium NV
Cardiac Monitor
K173872
510(k) premarket notification
Not available
https://bit.ly/2VOzZIr
2018 09
Cardiology
Irregular Rhythm Notification Feature
Apple Inc.
detection of atrial fibrillation
DEN180042
de novo pathway
Not available
https://bit.ly/2TqDMdo
2018 09
Cardiology
RightEye Vision System
RightEye, LLC
identifying visual tracking impairment
K181771
510(k) premarket notification
Not available
https://bit.ly/32XTIXC
2018 09
Ophthalmology
FluoroShield™
Omega Medical Imaging, LLC
Radiation dosage reduction
K191713
510(k) premarket notification
Not available
https://bit.ly/2Tsb23W
2018 10
Radiology
Embrace
Empatica Srl
wearable for seizure monitoring
K181861
510(k) premarket notification
Not available
https://bit.ly/3aCnC6n
2018 11
Neurology
iSchemaView RAPID
iSchemaView, Inc.
stroke detection on CT and MRI
K182130
510(k) premarket notification
Not available
https://bwnews.pr/32Xl1l4
2018 12
Radiology
Quantib ND
Quantib BV
Neurodegenerative disease MRI brain reading
K182564
510(k) premarket notification
Not available
https://bwnews.pr/2TI4LQP
2018 12
Radiology
Study Watch
Verily Life Sciences LLC
ECG feature of the Study Watch
K182456
510(k) premarket notification
Not available
https://bit.ly/38oRFgw
2019 01
Cardiology
KardiaAI
AliveCor, Inc
six-lead smartphone ECG
K181823
510(k) premarket notification
Not available
https://bit.ly/2vMd5a1
2019 03
Cardiology
Loop System
Spry Health, Inc.
Monitoring vital signs
K181352
510(k) premarket notification
Not available
https://bit.ly/2xgTzD8
2019 03
Hospital monitoring
RhythmAnalytics
Biofourmis Singapore Pte. Ltd
Monitoring cardiac arrhythmias
K182344
510(k) premarket notification
Not available
https://bit.ly/32TABhC
2019 03
Cardiology
eMurmer ID
CSD Labs GmbH
Heart murmur detection
K181988
510(k) premarket notification
Not available
https://bit.ly/2TI4zkz
2019 04
Cardiology
ReSET-O
Pear Therapeutics, Inc.
adjuvant treatment of substance abuse disorder
K173681
510(k) premarket notification
Not available
https://bit.ly/3cC0zKT
2019 5
Psychiatry
ACR | LAB Urine Analysis Test System
Healthy.io Ltd
Urinary tract infection diagnosis
K182384
510(k) premarket notification
Not available
https://bit.ly/3axoyJj
2019 07
Urology / General practise
Current Wearable Health Monitoring System
Current Health Ltd.
Monitoring vital signs
K191272
510(k) premarket notification
Not available
https://bit.ly/2VQDHBi
2019 07
Hospital monitoring
physIQ Heart Rhythm and Respiratory Module
physIQ, Inc
detection of atrial fibrillation
K183322
510(k) premarket notification
Not available
https://bit.ly/2TtjiAP
2019 07
Cardiology
RayCare 2.3
RaySearch Laboratories AB
Medical charged-particle radiation therapy system
K191384
510(k) premarket notification
Not available
https://bit.ly/2vB0yXb
2019 07
Radiology
Biovitals Analytics Engine
Biofourmis Singapore Pte. Ltd
Cardiac Monitor
K183282
510(k) premarket notification
Not available
https://bit.ly/2IrQbHW
2019 08
Cardiology
Caption Guidance
Caption Health, Inc.
Software to assist medical professionals in the acquisition of cardiac ultrasound images.
DEN190040
de novo pathway
artificial intelligence
2019 08
Radiology
BrainScope TBI
BrainScope Company, Inc
EEG-based Concussion Index
K190815
510(k) premarket notification
Not available
https://bit.ly/3azmYGZ
2019 09
Neurology
AIMI-Triage CXR PTX
RADLogics, Inc.
Chest X-ray prioritization service
K193300
510(k) premarket notification
artificial intelligence
2020 03
Radiology
EyeArt
Eyenuk, Inc
Automated detection of diabetic retinopathy
K200667
510(k) premarket notification
artificial intelligence
2020 06
Ophthalmology
qER
Qure.ai Technologies
Computer aided triage and notification software for CT images
K200921
510(k) premarket notification
artificial intelligence
2020 06
Radiology
Emergency Medicine
AVA (Augmented Vascular Analysis)
See-Mode Technologies Pte. Ltd.
Analysis and reporting of vascular ultrasound scans
K201369
510(k) premarket notification
artificial intelligence
2020 08
Radiology
Genius AI Detection
Hologic, Inc.
Software device intended to identify potential abnormalities in breast tomosynthesis images
K201019
510(k) premarket notification
machine learning
2020 11
Radiology
PixelShine
AlgoMedica
Algorithm used to de-noise CT datasets to increase image quality at reduced dose levels
K161625
510(k) premarket notification
Not available
https://bit.ly/3fv0YTo
2016 06
Radiology
Pathwork Tissue of Origin Test Kit-FFPE
Pathwork Diagnostics, Inc.
ML test to aid diagnosis of difficult-to-diagnose tumors using formalin-fixed, paraffin-embedded samples
K092967
510(k) premarket notification
machine learning
2010 06
Pathology
Oncology
CLEWICU System
CLEW Medical Ltd.
A.I.- driven Intensive care decision support system.
K200717
510(k) premarket notification
machine learning
2021 01
Hematology
Intensive care
red dot
Behold.AI Technologies Ltd.
Prioritisation of pneumothorax on chest X-rays
K191556
510(k) premarket notification
artificial intelligence
2020 02
Radiology
Pulmonology
Cognoa ASD Diagnosis Aid
Cognoa, Inc
Software aid in the diagnosis of Autism Spectrum Disorder
DEN200069
de novo pathway
Not available
https://bit.ly/2WzVnEl
2021 06
Pediatrics
Neurology
Quicktome
Omniscient Neurotechnology Pty Ltd
Digital brain mapping platform
K203518
510(k) premarket notification
Not available
https://bit.ly/3A2rSsp
2021 02
Radiology
Neurology
PAPNET Testing System
Neuromedical Systems Inc.
Semi-automated device indicated to aid in the rescreening of negative Pap test
P940029
PMA
Neural networks
1995 08
Pathology
Gynecology