AI Devices

Workflow & image management

Radiology AI devices in the Workflow & image management category, FDA-cleared or EU CE-marked, newest clearance first. Information only, never clinical advice.

US

DTX Studio Clinic (4.0)

🇸🇪Nobel Biocare AB

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2023
US

Bonelogic

Disior Ltd

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2023
US

LOGIQ Totus

🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2023
US

Myocardial Strain Software Application

🇨🇦Circle Cardiovascular Imaging

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2023
US

Aquilion Serve SP (TSX-307B/1) V1.3

🇯🇵Canon Medical Systems Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2023
US

EPIQ Series Diagnostic Ultrasound System

🇺🇸Philips Ultrasound, LLC

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2023
US

6440 MyLabX90

🇮🇹Esaote, S.p.A.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2023
US

BriefCase-Quantification

🇮🇱Aidoc Medical , Ltd.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2023
US

MAGNETOM Avanto fit; MAGNETOM Skyra fit

🇺🇸Siemens Medical Solutions USA, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2023
US

MAGNETOM Free.Max; MAGNETOM Free.Star

🇺🇸Siemens Medical Solutions USA, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2023
US

LOGIQ E10

🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2023
US

LOGIQ E10s, LOGIQ Fortis

GE Medical Systems Ultrasound and Primary Care Diagnostic,

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2023
US

Voluson Expert 22, Voluson Expert 20, Voluson Expert 18

🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2023
US

ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System

🇺🇸Siemens Medical Solutions USA, Inc.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2023
US

MeVis Liver Suite

🇩🇪MeVis Medical Solutions AG

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2023
US

SwiftMR

🇰🇷Airs Medical, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2023
US

Lumify Diagnostic Ultrasound System

🇺🇸Philips Ultrasound

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2023
US

MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit

🇺🇸Siemens Medical Solutions USA, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2023
US

Ultrasound System 1300

🇫🇷BK Medical Aps

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2023
US

Veuron-Brain-pAb3

🇰🇷Heuron Co., Ltd.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2023
US

SpotLight/SpotLight Duo (with DLIR option)

🇮🇱Arineta Ltd.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2023
US

NeuViz 128 Multi-Slice CT Scanner System

🇨🇳Neusoft Medical Systems Co., Ltd.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2023
US

Denti.AI Detect

🇨🇦Denti.AI Technology, Inc.

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2023
US

Swoop® Portable MR Imaging System®

🇺🇸Hyperfine, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2023
US

Clarius Ultrasound Scanner

🇨🇦Clarius Mobile Health Corp.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2023
US

DeepTek CXR Analyzer v1.0

🇮🇳DeepTek Medical Imaging Pvt Ltd

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2023
US

Momentum Spine

🇨🇦Momentum Health Inc.

Device, Sensing, Optical Contour

Multi-modalityWorkflow & image management510(k) 2023
US

uMI Panorama

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2023
US

V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System

🇰🇷Samsung Medison Co., Ltd.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2023
US

Lung-CAD

🇺🇸Imagen Technologies, Inc

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2023
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