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.
Viz RV/LV
🇺🇸Viz.ai, Inc.
MR image reconstruction/enhancement
BriefCase
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
MRI Planner
🇸🇪Spectronic Medical AB
System, Planning, Radiation Therapy Treatment
AutoContour Model RADAC V2
🇺🇸Radformation, Inc.
RT auto-contouring
HS40 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
MI View&GO
🇺🇸Siemens Medical Solutions USA, Inc.
MR image reconstruction/enhancement
TeraRecon Neuro
🇺🇸Terarecon,Inc.
System, Image Processing, Radiological
AI-Rad Companion (Pulmonary)
🇩🇪Siemens Healthcare GmbH
System, X-Ray, Tomography, Computed
ClearPoint Maestro Brain Model
🇺🇸ClearPoint Neuro, Inc.
MR image reconstruction/enhancement
Customize
3D-Side SA
MR image reconstruction/enhancement
Transpara 1.7.2
ScreenPoint Medical B.V.
Breast CAD (tomosynthesis)
ABMD Software
🇺🇸HeartLung Corporation
Densitometer, Bone
Deep Learning Image Reconstruction
🇯🇵Ge Healthcare Japan Corporation
System, X-Ray, Tomography, Computed
Swoop Portable MR Imaging System
🇺🇸Hyperfine, Inc.
System, Nuclear Magnetic Resonance Imaging
cvi42 Auto Imaging Software Application
🇨🇦Circle Cardiovascular Imaging, Inc.
MR image reconstruction/enhancement
Viz SDH
🇺🇸Viz.ai, Inc.
Triage & notification (CADt)
EchoPAC Software Only, EchoPAC Plug-in
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
MR image reconstruction/enhancement
AI4CMR v1.0
🇵🇹Ai4medimaging Medical Solutions S.A.
System, Image Processing, Radiological
Vivid E80, Vivid E90, Vivid E95
🇺🇸GE Medical Systems Ultrasound and
System, Imaging, Pulsed Doppler, Ultrasonic
Libby Echo:Prio
Dyad Medical, Inc
MR image reconstruction/enhancement
BrainInsight
🇺🇸Hyperfine, Inc.
MR image reconstruction/enhancement
Vivid iq
🇺🇸GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
Vivid T8, Vivid T9
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
Vivid S60N, Vivid S70N
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
syngo.CT Extended Functionality
🇺🇸Siemens Medical Solutions USA, Inc.
System, X-Ray, Tomography, Computed
ProstatID
🇺🇸ScanMed, LLC
Breast CAD (tomosynthesis)
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
Venue
🇺🇸GE Medical Systems
System, Imaging, Pulsed Doppler, Ultrasonic
Venue Fit
🇺🇸GE Medical Systems
System, Imaging, Pulsed Doppler, Ultrasonic
MAGNETOM Free.Max, MAGNETOM Free.Star
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
