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.
MSKai
MSKai
MR image reconstruction/enhancement
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
🇺🇸Philips Ultrasound, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Tomography, Computed, Emission
BriefCase-Triage
🇮🇱Aidoc Medical , Ltd.
Lesion detection/diagnosis software
IRISeg
🇺🇸Intuitive Surgical, Inc.
MR image reconstruction/enhancement
V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
AutoContour (Model RADAC V4)
🇺🇸Radformation, Inc.
RT auto-contouring
DrAid for Liver Segmentation
VinBrain Joint Stock Company
MR image reconstruction/enhancement
EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
Ever Fortune.Ai, Co., Ltd.
Triage & notification (CADt)
CDM Insights
🇬🇧Oxford Brain Diagnostics Ltd
MR image reconstruction/enhancement
PeekMed web
🇵🇹Peek Health, S.A.
System, Image Processing, Radiological
ClearRead CT CAC
Riverain Technologies, Inc.
System, X-Ray, Tomography, Computed
Sonix Health
🇰🇷Ontact Health Co., Ltd
MR image reconstruction/enhancement
HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
Transpara (2.1.0)
ScreenPoint Medical B.V.
Breast CAD (tomosynthesis)
BriefCase-Quantification
🇮🇱Aidoc Medical , Ltd.
MR image reconstruction/enhancement
Strain AI (SAI001)
Exo Inc
MR image reconstruction/enhancement
ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System
🇺🇸Siemens Medical Solutions USA, Inc.
System, Imaging, Pulsed Doppler, Ultrasonic
Saige-Dx
DeepHealth, Inc.
Breast CAD (tomosynthesis)
Koios DS
🇺🇸Koios Medical, Inc.
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
🇰🇷Vuno Inc.
Lesion detection/diagnosis software
The 5000 Compact Series Ultrasound Systems
🇺🇸Philips Ultrasound, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
1CMR Pro
Mycardium AI Limited
System, Image Processing, Radiological
Fetal EchoScan
🇫🇷Brightheart
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
ProFound Detection (V4.0)
🇺🇸iCAD, Inc.
Breast CAD (tomosynthesis)
NeuroICH
🇺🇸Neurocareai Inc.
Triage & notification (CADt)
icobrain aria
icometrix NV
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
TeraRecon Cardiac.Chambers.MR (1.0.0)
🇺🇸Terarecon,Inc.
MR image reconstruction/enhancement
RemedyLogic AI MRI Lumbar Spine Reader
Remedy Logic Inc.
MR image reconstruction/enhancement
TumorSight Viz
🇺🇸SimBioSys, Inc.
MR image reconstruction/enhancement
