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.
Red Dot
Behold.AI Technologies Limited
Lesion detection/diagnosis software
AccuContour
Xiamen Manteia Technology LTD.
RT auto-contouring
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
🇯🇵Canon Medical Systems Corporation
System, X-Ray, Tomography, Computed
densitas densityai
🇨🇦Densitas, Inc.
System, Image Processing, Radiological
Biograph Vision, Biograph mCT Family of PET/CTs
🇺🇸Siemens Medical Solutions USA, Inc.
System, Tomography, Computed, Emission
Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System
🇯🇵Canon Medical Systems Corporation
System, X-Ray, Tomography, Computed
Biograph Horizon
Siemens Medical Solution USA, Inc.
System, Tomography, Computed, Emission
Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon
🇺🇸Varian Medical Systems, Inc.
Accelerator, Linear, Medical
Caption Guidance
Bay Labs, Inc.
Image Acquisition And/Or Optimization Guided By Artificial Intelligence
MRCAT brain
Philips Medical Systems MR Finland
System, Planning, Radiation Therapy Treatment
Auto Positioning
🇨🇳GE Hangwei Medical Systems Co., Ltd.
System, X-Ray, Tomography, Computed
ADAS 3D
Galgo Medical S.L
System, Image Processing, Radiological
BriefCase
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
QLAB Advanced Quantification Software
🇨🇳Philips Healthcare
MR image reconstruction/enhancement
syngo.CT CaScoring
🇺🇸Siemens Medical Solutions USA, Inc.
System, X-Ray, Tomography, Computed
QyScore Software
🇫🇷Qynapse
System, Image Processing, Radiological
Deep Learning Image Reconstruction
🇯🇵Ge Healthcare Japan Corporation
System, X-Ray, Tomography, Computed
Icobrain
icometrix NV
System, Image Processing, Radiological
NemoScan
🇪🇸Software Nemotec S.L.
System, Image Processing, Radiological
Transpara
ScreenPoint Medical B.V.
Breast CAD (tomosynthesis)
PhantomMSK Trauma
🇺🇸OrthoGrid Systems Inc.
System, Image Processing, Radiological
HealthCXR
Zebra Medical Vision Ltd.
Lesion detection/diagnosis software
RSI-MRI+
MultiModal Imaging Services Corporation (dba HealthLytix)
System, Image Processing, Radiological
EchoGo Core
🇬🇧Ultromics Ltd
MR image reconstruction/enhancement
MEDIP PRO
MEDICALIP Co., Ltd
System, Image Processing, Radiological
Cleerly Labs
🇺🇸Cleerly, Inc.
System, Image Processing, Radiological
KOALA
🇫🇷IB Lab GmbH
System, Image Processing, Radiological
RTHawk, HeartVista Cardiac Package
HeartVista, Inc.
System, Nuclear Magnetic Resonance Imaging
Merge PACS
🇺🇸Merge Healthcare Incorporated
System, Image Processing, Radiological
Ventripoint Medical System Plus (VMS+) 3.0
🇨🇦Ventripoint Diagnostics Ltd.
System, Image Processing, Radiological
