Cleared in 2023
Radiology AI devices with a 2023 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.
uMI Panorama
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Tomography, Computed, Emission
V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
Lung-CAD
🇺🇸Imagen Technologies, Inc
Analyzer, Medical Image
HipCheck
🇺🇸Stryker Corp.
MR image reconstruction/enhancement
Brainomix 360 Triage LVO
🇬🇧Brainomix Limited
Triage & notification (CADt)
OFIX MIS App
🇺🇸Orthofix US LLC
System, Image Processing, Radiological
EFAI RTSUITE CT HCAP-Segmentation System
Ever Fortune.Ai, Co., Ltd.
RT auto-contouring
Annalise Enterprise CTB Triage Trauma
Annalise-AI Pty Ltd
Triage & notification (CADt)
qXR-CTR
🇮🇳Qure.Ai Technologies
MR image reconstruction/enhancement
Jazz
AI Medical AG
System, Image Processing, Radiological
Annalise Enterprise CTB Triage Trauma
Annalise-AI Pty Ltd
Triage & notification (CADt)
Overjet Periapical Radiolucency Assist
Overjet, Inc.
Analyzer, Medical Image
Aquilion Serve (TSX-307A/1) V1.3
🇯🇵Canon Medical Systems Corporation
System, X-Ray, Tomography, Computed
NEUROShield
In-Med Prognostics L3C
System, Image Processing, Radiological
Lung-CAD
🇺🇸Imagen Technologies, Inc
Analyzer, Medical Image
Cartesion Prime (PCD-1000A/3) V10.15
🇯🇵Canon Medical Systems Corporation
System, Tomography, Computed, Emission
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
🇯🇵Canon Medical Systems Corporation
System, X-Ray, Fluoroscopic, Image-Intensified
DeepXray
Alpha Intelligence Manifolds, Inc.
MR image reconstruction/enhancement
MAGNETOM Viato.Mobile
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
🇯🇵Canon Medical Systems Corporation
System, Nuclear Magnetic Resonance Imaging
VisAble.IO
🇮🇱Techsomed
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
AIRAscore
🇩🇪AIRAmed GmbH
System, Image Processing, Radiological
qXR-PTX-PE
🇮🇳Qure.Ai Technologies
Lesion detection/diagnosis software
Annalise Enterprise CTB Triage-OH
Annalise-AI Pty Ltd
Triage & notification (CADt)
VisiRad XR
Imidex Inc.
Analyzer, Medical Image
Brainomix 360 Triage ICH
🇬🇧Brainomix Limited
Triage & notification (CADt)
Rapid Aneurysm Triage and Notification
🇺🇸iSchemaView, Inc.
Lesion detection/diagnosis software
uMI Panorama
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Tomography, Computed, Emission
ANDI
🇨🇦Imeka Solutions, Inc.
MR image reconstruction/enhancement
Sonio Detect
🇨🇫Sonio
System, Imaging, Pulsed Doppler, Ultrasonic
