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.
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
🇺🇸Mighty Oak Medical
MR image reconstruction/enhancement
RUS
🇰🇷Hutom Inc.
MR image reconstruction/enhancement
BriefCase-Triage
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
SubtleSYNTH (1.x)
🇺🇸Subtle Medical, Inc.
MR image reconstruction/enhancement
SMART Bun-Yo-Matic X-Ray
Disior Ltd
MR image reconstruction/enhancement
Hyper Insight - ICH
🇰🇷SK Inc.
Triage & notification (CADt)
VEA Align; spineEOS
🇫🇷Eos Imaging
MR image reconstruction/enhancement
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
O-arm O2 Imaging System
🇺🇸Medtronic Navigation, Inc
Interventional Fluoroscopic X-Ray System
Medihub Prostate
🇰🇷JLK, Inc.
MR image reconstruction/enhancement
SMART Bun-Yo-Matic CT
Disior Ltd
MR image reconstruction/enhancement
SIS System
Surgical Information Sciences, Inc.
MR image reconstruction/enhancement
Clarius OB AI
🇨🇦Clarius Mobile Health Corp.
System, Imaging, Pulsed Doppler, Ultrasonic
Radiography 7300 C
🇩🇪Philips Medical Systems DMC GmbH
System, X-Ray, Stationary
Relu Creator
🇧🇪Relu BV
MR image reconstruction/enhancement
RS85 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
Cardiac CT Function Software Application
🇨🇦Circle Cardiovascular Imaging
MR image reconstruction/enhancement
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
Ever Fortune.Ai, Co., Ltd.
MR image reconstruction/enhancement
CINA-VCF
🇫🇷Avicenna.AI
Lesion detection/diagnosis software
uPMR 790
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
LVivo IQS
DiA Imaging Analysis Ltd.
MR image reconstruction/enhancement
Syngo Carbon Enterprise Access (VA40A)
🇩🇪Siemens Healthcare GmbH
System, Image Processing, Radiological
VinDr-Mammo
VinBigData Joint Stock Company
Lesion detection/diagnosis software
YSIO X.pree
🇩🇪Siemens Medical Solutions
System, X-Ray, Stationary
uOmnispace.CT
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
MR image reconstruction/enhancement
Heuron ICH
🇰🇷Heuron Co., Ltd.
Triage & notification (CADt)
BriefCase-Quantification
🇮🇱Aidoc Medical , Ltd.
MR image reconstruction/enhancement
SmartChest
🇫🇷Milvue
Lesion detection/diagnosis software
DeepContour (V1.0)
🇨🇳Wisdom Technologies., Inc.
RT auto-contouring
ECHELON Synergy V10.0
🇺🇸FUJIFILM Healthcare Americas Corporation
System, Nuclear Magnetic Resonance Imaging
