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.
EdgeFlow UH10
🇰🇷Edgecare Inc.
System, Imaging, Pulsed Echo, Ultrasonic
Overjet Caries Assist-Pediatric
Overjet, Inc.
Analyzer, Medical Image
BoneMRI
🇳🇱MRIguidance B.V
MR image reconstruction/enhancement
iCAS-LV
HighRAD Ltd.
MR image reconstruction/enhancement
MAGNETOM Cima.X Fit
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
inHEART Models
inHEART, SAS
MR image reconstruction/enhancement
CT Cardiomegaly
Innolitics, LLC
MR image reconstruction/enhancement
Overjet Charting Assist
Overjet, Inc.
MR image reconstruction/enhancement
Revolution Ascend Sliding
🇨🇳GE Hangwei Medical Systems Co., Ltd.
System, X-Ray, Tomography, Computed
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
🇺🇸Philips Ultrasound, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
QOCA® image Smart RT Contouring System
🇹🇼Quanta Computer Inc.
RT auto-contouring
HealthFLD
🇮🇱Nano-X AI Ltd.
System, X-Ray, Tomography, Computed
Viz HDS, Viz Volume Plus, Viz ICH+
🇺🇸Viz.ai, Inc.
MR image reconstruction/enhancement
CEPHX- Cephalometric Analysis Software
Orca Dental AI , Ltd.
System, Image Processing, Radiological
Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System
🇯🇵Canon Medical Systems Corporation
System, Imaging, Pulsed Doppler, Ultrasonic
SIGNA Champion
🇨🇳GE Healthcare (Tianjin) Company Limited
System, Nuclear Magnetic Resonance Imaging
Rapid ASPECTS (v3)
🇺🇸iSchemaView, Inc.
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
NemoScan
🇪🇸Software Nemotec S.L.
MR image reconstruction/enhancement
Radify Triage
Envisionit DeepAI Ltd
Lesion detection/diagnosis software
Rapid (6.0)
🇺🇸iSchemaView, Inc.
MR image reconstruction/enhancement
Biograph VK10
🇺🇸Siemens Medical Solutions USA, Inc.
System, Tomography, Computed, Emission
Fibresolve
Imvaria, Inc.
Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
DASI Dimensions (V1.0)
🇺🇸DASI Simulations
MR image reconstruction/enhancement
LungQ v3.0.0
🇳🇱Thirona BV
System, X-Ray, Tomography, Computed
VEA Align
🇫🇷Eos Imaging
MR image reconstruction/enhancement
Butterfly iQ3 Ultrasound System
🇺🇸Butterfly Network, Inc.
System, Imaging, Pulsed Doppler, Ultrasonic
TumorSight Viz
🇺🇸SimBioSys, Inc.
MR image reconstruction/enhancement
MAGNETOM Sola; MAGNETOM Altea
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
ART-Plan
🇫🇷TheraPanacea
System, Planning, Radiation Therapy Treatment
qXR-LN
🇮🇳Qure.Ai Technologies
Analyzer, Medical Image
