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.
syngo.CT Extended Functionality
🇺🇸Siemens Medical Solutions USA, Inc.
System, X-Ray, Tomography, Computed
SIGNA Hero
GE Healthcare (GE Medical Systems, LLC)
System, Nuclear Magnetic Resonance Imaging
Caption Interpretation Automated Ejection Fraction Software
Caption Health
MR image reconstruction/enhancement
Follicle Clarity
🇺🇸Cycle Clarity
MR image reconstruction/enhancement
SIGNA Prime
🇨🇳GE Healthcare (Tianjin) Company Limited
System, Nuclear Magnetic Resonance Imaging
Precise Image
🇳🇱Philips Medical Systems Nederland B.V.
System, X-Ray, Tomography, Computed
Eclipse II with Smart Noise Cancellation
🇺🇸Carestream Health, Inc.
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Quantib ND
Quantib B.V.
System, Image Processing, Radiological
Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert
🇺🇸GE Healthcare
System, Imaging, Pulsed Doppler, Ultrasonic
UNiD Spine Analyzer
MEDICREA International, Inc.
System, Image Processing, Radiological
AIBOLIT 3D+
Aibolit Technologies, LLC
System, Image Processing, Radiological
TOMTEC-ARENA
🇩🇪TOMTEC Imaging Systems GmbH
MR image reconstruction/enhancement
LiverSmart
🇦🇺Resonance Health Analysis Services Pty Ltd
Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
BoneMRI
🇳🇱MRIguidance B.V
MR image reconstruction/enhancement
qXR-BT
🇮🇳Qure.Ai Technologies
MR image reconstruction/enhancement
BU-CAD
TaiHao Medical Inc.
Breast CAD (tomosynthesis)
EchoGo Core (2.0)
Ultromics Limited
MR image reconstruction/enhancement
VBrain
Vysioneer Inc.
RT auto-contouring
Koios DS
🇺🇸Koios Medical, Inc.
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
RT-Mind-AI
🇨🇳MedMind Technology Co., Ltd.
RT auto-contouring
HealthPPT
Zebra Medical Vision Ltd.
Lesion detection/diagnosis software
LVivo Seamless
DiA Imaging Analysis Ltd.
MR image reconstruction/enhancement
Al-Rad Companion (Pulmonary)
🇺🇸Siemens Medical Solutions USA, Inc.
System, X-Ray, Tomography, Computed
Cydar EV (Series B) and Cydar EV Maps
🇬🇧Cydar Ltd.
Interventional Fluoroscopic X-Ray System
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
🇯🇵Canon Medical Systems Corporation
System, Nuclear Magnetic Resonance Imaging
MammoScreen 2.0
🇺🇸Therapixel
Breast CAD (tomosynthesis)
OnQ Neuro
🇺🇸CorTechs Labs, Inc.
MR image reconstruction/enhancement
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
🇺🇸Hyperfine, Inc.
System, Nuclear Magnetic Resonance Imaging
Soteria.AI
🇺🇸Omega Medical Imaging, LLC
Interventional Fluoroscopic X-Ray System
Lunit INSIGHT MMG
🇰🇷Lunit, Inc.
Breast CAD (tomosynthesis)
