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.
HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
ViewFinder Software Version 1.1
Elaitra Ltd
MR image reconstruction/enhancement
Velacur
🇨🇦Sonic Incytes
System, Imaging, Pulsed Echo, Ultrasonic
Deep Learning Image Reconstruction
🇯🇵Ge Healthcare Japan Corporation
System, X-Ray, Tomography, Computed
ART-Plan
Therapanacea Sas
RT auto-contouring
Quantib Prostate
🇳🇱Quantib BV
System, Image Processing, Radiological
AutoContour Model RADAC V3
🇺🇸Radformation, Inc.
RT auto-contouring
Ezra Flash
🇺🇸Ezra AI, Inc.
System, Image Processing, Radiological
CerebralGo Plus
Yukun (Beijing) Technology Co., Ltd
MR image reconstruction/enhancement
Ultrasound System 2300
🇫🇷BK Medical Aps
System, Imaging, Pulsed Doppler, Ultrasonic
Limbus Contour
Limbus AI Inc.
System, Image Processing, Radiological
AI-Rad Companion (Cardiovascular)
Siemens Medical Solutions U.S.A.
System, X-Ray, Tomography, Computed
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems
🇳🇱Philips Medical Systems Nederland B.V.
System, Nuclear Magnetic Resonance Imaging
Contour ProtégéAI
🇺🇸Mim Software, Inc.
RT auto-contouring
Annalise Enterprise CTB Triage Trauma
Annalise-AI Pty Ltd
Triage & notification (CADt)
Butterfly iQ/iQ+ Ultrasound System
🇺🇸Butterfly Network, Inc.
System, Imaging, Pulsed Echo, Ultrasonic
Formus Hip
Formus Labs, Ltd
MR image reconstruction/enhancement
RayStation 12A
🇸🇪RaySearch Laboratories AB (PUBL)
System, Planning, Radiation Therapy Treatment
DTX Studio Clinic 3.0
🇸🇪Nobel Biocare AB
Analyzer, Medical Image
RadioLens v1.0
Synapsica
MR image reconstruction/enhancement
Annalise Enterprise CXR Triage Trauma
Annalise-AI Pty Ltd
Lesion detection/diagnosis software
Annalise Enterprise CXR Triage Trauma
Annalise-AI Pty Ltd
Lesion detection/diagnosis software
MAGNETOM Amira; MAGNETOM Sempra
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
Overjet Caries Assist
Overjet, Inc.
Analyzer, Medical Image
MPXA-2000
🇰🇷Medipixel, Inc.
MR image reconstruction/enhancement
FlightPlan for Embolization
🇫🇷GE Medical Systems SCS
System, Image Processing, Radiological
Viz AAA
🇺🇸Viz.ai, Inc.
Lesion detection/diagnosis software
uMI Panorama
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Tomography, Computed, Emission
Spectral Bone Marrow
🇺🇸Ge Medical Systems, LLC
System, X-Ray, Tomography, Computed
AccuContour
🇨🇳Manteia Technologies Co., Ltd.
RT auto-contouring
