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.
HM70 EVO Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
uOmnispace.MI
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Image Processing, Radiological
MAGNETOM Cima.X
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
iQ-solutions
🇦🇺Sydney Neuroimaging Analysis Centre Pty Ltd
MR image reconstruction/enhancement
Videa Dental Assist
🇺🇸VideaHealth Inc.
Analyzer, Medical Image
StrokeViewer Perfusion
🇳🇱NICo-Lab B.V.
System, Image Processing, Radiological
QP-Brain®
🇪🇸Quibim S.L.
MR image reconstruction/enhancement
Transpara Density 1.0.0
ScreenPoint Medical B.V.
MR image reconstruction/enhancement
DTX Studio Clinic (4.0)
🇸🇪Nobel Biocare AB
System, Image Processing, Radiological
Bonelogic
Disior Ltd
System, Image Processing, Radiological
LOGIQ Totus
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
Myocardial Strain Software Application
🇨🇦Circle Cardiovascular Imaging
System, Image Processing, Radiological
Aquilion Serve SP (TSX-307B/1) V1.3
🇯🇵Canon Medical Systems Corporation
System, X-Ray, Tomography, Computed
Adravision Perio
Adra Corporation
MR image reconstruction/enhancement
Ceevra Reveal 3+
🇺🇸Ceevra, Inc.
MR image reconstruction/enhancement
Syngo Carbon Clinicals
🇩🇪Siemens Healthcare GmbH
MR image reconstruction/enhancement
EPIQ Series Diagnostic Ultrasound System
🇺🇸Philips Ultrasound, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
6440 MyLabX90
🇮🇹Esaote, S.p.A.
System, Imaging, Pulsed Doppler, Ultrasonic
BriefCase-Quantification
🇮🇱Aidoc Medical , Ltd.
System, X-Ray, Tomography, Computed
syngo.via MI Workflows; Scenium; syngo MBF
🇺🇸Siemens Medical Solutions USA, Inc.
MR image reconstruction/enhancement
Brainomix 360 Triage Stroke
🇬🇧Brainomix Limited
Triage & notification (CADt)
AI Platform (AIP001)
Exo Inc
MR image reconstruction/enhancement
Axial3D Insight
🇬🇧Axial Medical Printing Limited
MR image reconstruction/enhancement
MAGNETOM Avanto fit; MAGNETOM Skyra fit
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
BriefCase-Quantification
🇮🇱Aidoc Medical , Ltd.
MR image reconstruction/enhancement
Clarius Bladder AI
🇨🇦Clarius Mobile Health Corp.
MR image reconstruction/enhancement
BraveCX
Bering Ltd
Lesion detection/diagnosis software
MAGNETOM Free.Max; MAGNETOM Free.Star
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
BriefCase-Quantification
🇮🇱Aidoc Medical , Ltd.
MR image reconstruction/enhancement
Contour ProtégéAI
🇺🇸Mim Software, Inc.
RT auto-contouring
