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) |
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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 |