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.
Swoop Portable MR Imaging System
🇺🇸Hyperfine, Inc.
System, Nuclear Magnetic Resonance Imaging
BriefCase
🇮🇱Aidoc Medical , Ltd.
Lesion detection/diagnosis software
Avenda Health AI Prostate Cancer Planning Software
🇺🇸Avenda Health, Inc.
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
CINA
🇫🇷Avicenna.AI
Triage & notification (CADt)
SIS System (Version 5.6.0)
Surgical Information Sciences, Inc.
MR image reconstruction/enhancement
BriefCase
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
BoneMRI v1.4
MRlguidance B.V.
MR image reconstruction/enhancement
Syngo Dynamics (Version VA40F)
🇺🇸Siemens Medical Solutions USA, Inc.
MR image reconstruction/enhancement
AVIEW RT ACS
🇰🇷Coreline Soft Co.,Ltd
RT auto-contouring
EFAI ChestSuite XR Pneumothorax Assessment System
Ever Fortune.Ai, Co., Ltd.
Lesion detection/diagnosis software
uMR Omega with uWS-MR-MRS
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Nuclear Magnetic Resonance Imaging
EndoNaut
Therenva SAS
Interventional Fluoroscopic X-Ray System
Viz LVO ContaCT
🇺🇸Viz.ai, Inc.
Triage & notification (CADt)
AI-Rad Companion (Musculoskeletal)
🇺🇸Siemens Medical Solutions USA, Inc.
System, X-Ray, Tomography, Computed
Spine CAMP
🇺🇸Medical Metrics, Inc.
MR image reconstruction/enhancement
AI-Rad Companion Organs RT
🇺🇸Siemens Medical Solutions USA, Inc.
RT auto-contouring
BriefCase
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
Genius AI Detection 2.0
🇺🇸Hologic, Inc.
Breast CAD (tomosynthesis)
QIR Suite
CASIS Cardiac Simulation & Imaging Software
MR image reconstruction/enhancement
CogNet QmTRIAGE
🇺🇸Medcognetics, Inc.
Lesion detection/diagnosis software
BriefCase
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
NS-HGlio
🇺🇸Neosoma, Inc.
MR image reconstruction/enhancement
Aorta-CAD
🇺🇸Imagen Technologies, Inc
Analyzer, Medical Image
MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
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
DrAid for Radiology v1
VinBrain Joint Stock Company
Lesion detection/diagnosis software
