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.
Cartesion Prime (PCD-1000A/3) V10.21
🇯🇵Canon Medical Systems Corporation
System, Tomography, Computed, Emission
CT VScore+
🇺🇸Canon Medical Informatics, Inc.
System, X-Ray, Tomography, Computed
OEC One CFD
Ge Hualun Medical Systems Co. , Ltd.
Image-Intensified Fluoroscopic X-Ray System, Mobile
Scaida BrainCT-ICH (v1.0)
Mlhealth 360
Triage & notification (CADt)
7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
🇮🇹Esaote, S.p.A.
System, Imaging, Pulsed Doppler, Ultrasonic
Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
a2z-Unified-Triage
A2z Radiology Ai, Inc.
Triage & notification (CADt)
Senographe Pristina 3D
🇺🇸GE Healthcare
Digital Breast Tomosynthesis
MAGNETOM Free.Max; MAGNETOM Free.Star
🇨🇳Siemens Shenzhen Magnetic Resonance , Ltd.
System, Nuclear Magnetic Resonance Imaging
DTX Studio Assist
🇧🇪Nobel Biocare C/O Medicim NV
Analyzer, Medical Image
Second Opinion® Panoramic
🇺🇸Pearl, Inc.
Analyzer, Medical Image
AutoDensity
🇫🇷Eos Imaging
MR image reconstruction/enhancement
PeekMed web
🇵🇹Peek Health, S.A.
MR image reconstruction/enhancement
SugarBug (1.x)
🇺🇸Bench7, Inc.
Analyzer, Medical Image
Fibresolve (with PCCP)
Imvaria, Inc.
Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
BriefCase-Triage
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
3mensio Workstation
Pie Medical Imaging BV
MR image reconstruction/enhancement
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
🇺🇸Mighty Oak Medical
System, Image Processing, Radiological
Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
🇯🇵Canon Medical Systems Corporation
System, Imaging, Pulsed Doppler, Ultrasonic
AiORTA - Plan
🇨🇦ViTAA Medical Solutions, Inc.
MR image reconstruction/enhancement
LOGIQ E10
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
LOGIQ E10s
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
cvi42 Coronary Plaque Software Application
🇨🇦Circle Cardiovascular Imaging, Inc.
MR image reconstruction/enhancement
Syngo Carbon Clinicals (VA41)
🇩🇪Siemens Healthineers AG
MR image reconstruction/enhancement
TeraRecon Cardiovascular.Calcification.CT
🇺🇸Terarecon,Inc.
MR image reconstruction/enhancement
ANDI 2.0
🇨🇦Imeka Solutions, Inc.
MR image reconstruction/enhancement
brAIn Shoulder Positioning
🇺🇸Avatar Medical
MR image reconstruction/enhancement
X9 Ultrasound System
🇺🇸X9, Inc.
Ultrasound Imaging For Vascular Access For Hemodialysis
X1-FFR
🇺🇸Spectrawave, Inc.
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
🇯🇵Canon Medical Systems Corporation
Interventional Fluoroscopic X-Ray System
