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.
uCT ATLAS with uWS-CT-Dual Energy Analysis
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, X-Ray, Tomography, Computed
Vereos PET/CT
🇳🇱Philips Medical Systems Nederland B.V.
System, Tomography, Computed, Emission
Kosmos
🇺🇸EchoNous, Inc.
System, Imaging, Pulsed Doppler, Ultrasonic
breastscape v1.0
🇫🇷Olea Medical
MR image reconstruction/enhancement
qER-Quant
🇮🇳Qure.Ai Technologies
MR image reconstruction/enhancement
syngo.via RT Image Suite
🇺🇸Siemens Medical Solutions USA, Inc.
System, Planning, Radiation Therapy Treatment
aPROMISE
🇸🇪EXINI Diagnostics AB
System, Image Processing, Radiological
ClariCT.AI
🇰🇷ClariPi Inc.
System, Image Processing, Radiological
Volpara Imaging Software
Volpara Health Technologies Limited
System, Image Processing, Radiological
Us2.v1
Eko.ai Pte. Ltd d/b/a Us2.ai
MR image reconstruction/enhancement
Chest-CAD
🇺🇸Imagen Technologies, Inc
Analyzer, Medical Image
Change Healthcare Anatomical AI
🇨🇦Change Healthcare Canada Company
MR image reconstruction/enhancement
PowerLook Density Assessment V4.0
🇺🇸iCAD, Inc.
MR image reconstruction/enhancement
HALO
🇳🇱NICo-Lab B.V.
Triage & notification (CADt)
MAGNETOM Free.Max
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
RayStation 10.1
🇸🇪RaySearch Laboratories AB (PUBL)
System, Planning, Radiation Therapy Treatment
Precise Position
🇨🇳Philips Healthcare (Suzhou) Co., Ltd.
System, X-Ray, Tomography, Computed
Qmenta Care Platform Family
Mint Labs, Inc., d/b/a. QMENTA
System, Image Processing, Radiological
syngo.via MI WorkFlows, Scenium, syngo MBF
🇺🇸Siemens Medical Solutions USA, Inc.
MR image reconstruction/enhancement
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
🇺🇸Abbott Medical
System, Imaging, Optical Coherence Tomography (Oct)
Transpara 1.7.0
ScreenPoint Medical B.V.
Breast CAD (tomosynthesis)
CINA CHEST
🇫🇷Avicenna.AI
Triage & notification (CADt)
Overjet Dental Assist
Overjet, Inc.
System, Image Processing, Radiological
SIGNA 7.0T
🇺🇸Ge Medical Systems, LLC
System, Nuclear Magnetic Resonance Imaging
HS40 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
Radformation AutoContour
🇺🇸Radformation
RT auto-contouring
HYPER AiR
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Tomography, Computed, Emission
Cartesion Prime (PCD-1000A/3) V10.8
🇯🇵Canon Medical Systems Corporation
System, Tomography, Computed, Emission
MEDO-Thyroid
MEDO DX Pte. Ltd.
MR image reconstruction/enhancement
Preview Shoulder
🇺🇸Genesis Software Innovations
MR image reconstruction/enhancement
