AI Devices

Cleared in 2020

Radiology AI devices with a 2020 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.

US

Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i

🇯🇵Canon Medical Systems Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2020
US

densitas densityai

🇨🇦Densitas, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
US

Biograph Vision, Biograph mCT Family of PET/CTs

🇺🇸Siemens Medical Solutions USA, Inc.

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2020
US

Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System

🇯🇵Canon Medical Systems Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2020
US

Biograph Horizon

Siemens Medical Solution USA, Inc.

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2020
US

Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon

🇺🇸Varian Medical Systems, Inc.

Accelerator, Linear, Medical

Multi-modalityWorkflow & image management510(k) 2020
US

Caption Guidance

Bay Labs, Inc.

Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Multi-modalityWorkflow & image managementDe Novo 2020
US

MRCAT brain

Philips Medical Systems MR Finland

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2020
US

Auto Positioning

🇨🇳GE Hangwei Medical Systems Co., Ltd.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2020
US

ADAS 3D

Galgo Medical S.L

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
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