FDA-cleared — AI devices
Radiology AI devices on the FDA's AI-Enabled Device List (the Radiology panel). The list is not comprehensive and lags publication of decision summaries. Information only, never clinical advice.
Clarius Ultrasound Scanner
🇨🇦Clarius Mobile Health Corp.
System, Imaging, Pulsed Doppler, Ultrasonic
Ventripoint Medical System Plus (VMS+)
🇨🇦Ventripoint Diagnostics Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
Venue
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
Viz CTP
🇺🇸Viz.ai, Inc.
System, Image Processing, Radiological
DR 800 with MUSICA Dynamic
🇧🇪Agfa HealthCare N.V.
System, X-Ray, Fluoroscopic, Image-Intensified
Quantib Brain
🇳🇱Quantib BV
System, Image Processing, Radiological
iQMR
Medic Vision - Imaging Solutions Ltd
System, Image Processing, Radiological
DM-Density
🇨🇦Densitas, Inc.
System, Image Processing, Radiological
ContaCT
Viz.Al, Inc.
Triage & notification (CADt)
UNiD Spine Analyzer
🇫🇷Medicrea International
System, Image Processing, Radiological
Arterys Oncology DL
🇺🇸Arterys, Inc.
System, Image Processing, Radiological
Illumeo System
🇮🇱Philips Medical Systems Technologies , Ltd.
System, Image Processing, Radiological
cNeuro cMRI
Combinostics Oy
System, Image Processing, Radiological
Radiomics App v1.0
🇺🇸Microsoft Corp.
System, Image Processing, Radiological
Infinitt PACS 7.0
🇰🇷Infinitt Healthcare Co.,Ltd.
System, Image Processing, Radiological
Quantra
🇺🇸Hologic, Inc.
System, Image Processing, Radiological
BladderScan Prime PLUS System
Verathon Incorporated
System, Imaging, Pulsed Echo, Ultrasonic
Clarius Ultrasound System
🇨🇦Clarius Mobile Health Corp.
System, Imaging, Pulsed Doppler, Ultrasonic
NeuroQuant
🇺🇸CorTechs Labs, Inc.
System, Image Processing, Radiological
QuantX
Quantitative Insights, Inc
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
syngo Application Software
🇺🇸Siemens Medical Solutions USA, Inc.
System, Image Processing, Radiological
SmartTarget
SmartTarget, Ltd.
System, Image Processing, Radiological
UNiD Spine Analyzer
🇫🇷Medicrea International
System, Image Processing, Radiological
Lung Vision
🇮🇱Body Vision Medical Ltd.
System, Image Processing, Radiological
AmCAD-UV
🇹🇼AmCad BioMed Corporation
System, Image Processing, Radiological
PowerLook® Tomo Detection Software
🇺🇸iCAD, Inc.
Analyzer, Medical Image
SIS Software
Surgical Information Sciences, Inc.
System, Image Processing, Radiological
Quantib Brain 1.2
🇳🇱Quantib BV
System, Image Processing, Radiological
Arterys Cardio DL
🇺🇸Arterys, Inc.
System, Image Processing, Radiological
ClearView cCAD
ClearView Diagnostics Inc.
System, Image Processing, Radiological
