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.
SurgiTwin
Twinsight
System, Image Processing, Radiological
PRAEVAorta®2
Nurea
MR image reconstruction/enhancement
Definium Tempo Select
Ge Hualun Medical Systems Co. , Ltd.
System, X-Ray, Stationary
Brainomix 360 Triage Stroke
🇬🇧Brainomix Limited
Triage & notification (CADt)
GBrain MRI
Galileo CDS, Inc
MR image reconstruction/enhancement
MammoScreen BD
🇺🇸Therapixel
MR image reconstruction/enhancement
Vista OS, Vista AI Scan, RTHawk
🇺🇸Vista AI, Inc.
System, Nuclear Magnetic Resonance Imaging
Methinks CTA Stroke
Methinks Software S.L.
Triage & notification (CADt)
Salix Coronary Plaque (V1.0.0)
Artrya Limited
MR image reconstruction/enhancement
ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System
🇺🇸Siemens Medical Solutions USA, Inc.
System, Imaging, Pulsed Doppler, Ultrasonic
VEA Align; spineEOS
🇫🇷Eos Imaging
MR image reconstruction/enhancement
DS Core Diagnosis
🇺🇸Dentsply Sirona, Inc.
MR image reconstruction/enhancement
Saige-Dx
DeepHealth, Inc.
Breast CAD (tomosynthesis)
UNiD Spine Analyzer
Medicrea International S.A.S. (Medtronic)
MR image reconstruction/enhancement
uMR Jupiter
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Nuclear Magnetic Resonance Imaging
Revolution Vibe
🇺🇸Ge Medical Systems, LLC
System, X-Ray, Tomography, Computed
Genius AI Detection 2.0
🇺🇸Hologic, Inc.
Breast CAD (tomosynthesis)
YSIO X.pree
🇩🇪Siemens Medical Solutions
System, X-Ray, Stationary
Voxel Dosimetry (00859873006226)
🇸🇪Hermes Medical Solutions AB
MR image reconstruction/enhancement
Venue; Venue Go; Venue Fit; Venue Sprint
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
🇺🇸Philips Ultrasound, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
Neuro Insight V1.0
Olea Medical S.A.S.
System, Image Processing, Radiological
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
🇯🇵Canon Medical Systems Corporation
System, Nuclear Magnetic Resonance Imaging
GyriCalc (Version 1.0.0)
NeuroSpectrum Insights Corp.
System, Image Processing, Radiological
V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
uMR Ultra
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Nuclear Magnetic Resonance Imaging
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Tomography, Computed, Emission
uMR 680
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Nuclear Magnetic Resonance Imaging
Rapid CTA 360
🇺🇸iSchemaView
Triage & notification (CADt)
EchoPAC Software Only / EchoPAC Plug-in
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
MR image reconstruction/enhancement
