Cleared in 2022
Radiology AI devices with a 2022 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.
Rapid ICH
🇺🇸iSchemaView, Inc.
Triage & notification (CADt)
Aquilion Precision (TSX-304A/4) V10.10 with AiCE
🇯🇵Canon Medical Systems Corporation
System, X-Ray, Tomography, Computed
EFAI ChestSuite XR Pleural Effusion Assessment System
Ever Fortune.Ai, Co., Ltd.
Lesion detection/diagnosis software
syngo.via RT Image Suite
🇺🇸Siemens Medical Solutions USA, Inc.
System, Planning, Radiation Therapy Treatment
LiverMultiScan v5 (LMSv5)
🇬🇧Perspectum
System, Nuclear Magnetic Resonance Imaging
AIRS SwiftMR
🇰🇷AIRS Medical
MR image reconstruction/enhancement
DrAid for Radiology v1
VinBrain Joint Stock Company
Lesion detection/diagnosis software
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
