AI Devices

Cleared in 2022

Radiology AI devices with a 2022 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.

US

Voluson P6, Voluson P8

🇺🇸GE Healthcare

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2022
US

SIGNA Artist Evo

🇨🇳GE Healthcare (Tianjin) Company Limited

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2022
US

Rapid

iSchema View Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2022
US

Micro C Medical Imaging System, M01

🇺🇸OXOS Medical, Inc.

System, X-Ray, Mobile

Multi-modalityWorkflow & image management510(k) 2022
US

Revolution Ascend

🇯🇵Ge Healthcare Japan Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2022
US

Contour ProtégéAI

🇺🇸Mim Software, Inc.

RT auto-contouring

CTSegmentation510(k) 2022
EmergencyUS

syngo.CT Brain Hemorrhage

🇺🇸Siemens Medical Solutions USA, Inc.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2022
US

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5

🇯🇵Canon Medical Systems Corporation

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2022
US

syngo.CT Extended Functionality

🇺🇸Siemens Medical Solutions USA, Inc.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2022
US

SIGNA Hero

GE Healthcare (GE Medical Systems, LLC)

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2022
US

Caption Interpretation Automated Ejection Fraction Software

Caption Health

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2022
US

Follicle Clarity

🇺🇸Cycle Clarity

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2022
US

SIGNA Prime

🇨🇳GE Healthcare (Tianjin) Company Limited

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2022
US

Precise Image

🇳🇱Philips Medical Systems Nederland B.V.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2022
US

Eclipse II with Smart Noise Cancellation

🇺🇸Carestream Health, Inc.

Solid State X-Ray Imager (Flat Panel/Digital Imager)

Multi-modalityWorkflow & image management510(k) 2022
US

Quantib ND

Quantib B.V.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2022
US

Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert

🇺🇸GE Healthcare

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2022
US

UNiD Spine Analyzer

MEDICREA International, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2022
US

AIBOLIT 3D+

Aibolit Technologies, LLC

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2022
US

TOMTEC-ARENA

🇩🇪TOMTEC Imaging Systems GmbH

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2022
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