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.
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
🇺🇸Philips Ultrasound, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
AIAS Cephalon
🇩🇪Metamorphosis GmbH
MR image reconstruction/enhancement
BlineSlide
Deep Breathe, Inc.
MR image reconstruction/enhancement
Bunkerhill MAC
🇺🇸BunkerHill Health
System, X-Ray, Tomography, Computed
LungQ 4
🇳🇱Thirona BV
System, X-Ray, Tomography, Computed
SMART PCFD
Disior Ltd
MR image reconstruction/enhancement
Ligence Heart
Ligence Uab
MR image reconstruction/enhancement
uMR 680
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Nuclear Magnetic Resonance Imaging
Brain WMH
🇳🇱Quantib BV
MR image reconstruction/enhancement
SwiftSight-Brain
🇰🇷Airs Medical, Inc.
MR image reconstruction/enhancement
Rapid Aortic Measurements
🇺🇸iSchemaView, Inc.
MR image reconstruction/enhancement
uDR Aurora CX
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, X-Ray, Stationary
Videa Dental AI
🇺🇸VideaHealth Inc.
Analyzer, Medical Image
Axial3D Insight
🇬🇧Axial Medical Printing Limited
MR image reconstruction/enhancement
ECHELON Synergy
🇯🇵Fujifilm Corporation
System, Nuclear Magnetic Resonance Imaging
InferOperate Suite
Beijing Infervision Healthcare Medical Technology Co., Ltd.
MR image reconstruction/enhancement
FETOLY
🇫🇷Diagnoly
System, Imaging, Pulsed Doppler, Ultrasonic
SIGNA Sprint
🇺🇸Ge Medical Systems, LLC
System, Nuclear Magnetic Resonance Imaging
AngioWaveNet
🇺🇸Angiowave Imaging, Inc.
MR image reconstruction/enhancement
Segmentron Viewer
🇺🇸DGNCT, LLC
MR image reconstruction/enhancement
MuscleView 2.0
Springbok, Inc. (dba Springbok Analytics)
System, Nuclear Magnetic Resonance Imaging
BioTraceIO Vision (V1.7)
Techsomed Medical Technologies
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
qER-CTA (v1.0)
🇮🇳Qure.Ai Technologies
Triage & notification (CADt)
Rapid Obstructive Hydrocephalus, Rapid OH
🇺🇸iSchemaView, Inc.
Triage & notification (CADt)
Dose+ (1.0)
🇫🇮Mvision AI Oy
System, Planning, Radiation Therapy Treatment
Careverse CoronaryDoc (Careverse CoronaryDoc)
Careverse Technology Pte. Ltd.
MR image reconstruction/enhancement
Tempus Pixel
🇺🇸Arterys, Inc.
MR image reconstruction/enhancement
OsteoSight Hip (v1)
🇬🇧Naitive Technologies Ltd
Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
VELMENI for DENTISTS (V4D)
Velmeni Inc.
Analyzer, Medical Image
Sonosite LX and Sonosite PX Ultrasound Systems
🇺🇸Fujifilm Sonosite Inc
System, Imaging, Pulsed Doppler, Ultrasonic
