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

OFIX MIS App

🇺🇸Orthofix US LLC

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2023
US

Jazz

AI Medical AG

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2023
US

Overjet Periapical Radiolucency Assist

Overjet, Inc.

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2023
US

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

🇯🇵Canon Medical Systems Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2023
US

NEUROShield

In-Med Prognostics L3C

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2023
US

Lung-CAD

🇺🇸Imagen Technologies, Inc

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2023
US

Cartesion Prime (PCD-1000A/3) V10.15

🇯🇵Canon Medical Systems Corporation

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2023
US

XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5

🇯🇵Canon Medical Systems Corporation

System, X-Ray, Fluoroscopic, Image-Intensified

Multi-modalityWorkflow & image management510(k) 2023
US

MAGNETOM Viato.Mobile

🇺🇸Siemens Medical Solutions USA, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2023
US

Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR

🇯🇵Canon Medical Systems Corporation

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2023
US

VisAble.IO

🇮🇱Techsomed

Radiological Image Processing Software For Ablation Therapy Planning And Evaluation

Multi-modalityWorkflow & image management510(k) 2023
US

AIRAscore

🇩🇪AIRAmed GmbH

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2023
US

VisiRad XR

Imidex Inc.

Analyzer, Medical Image

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

Sonio Detect

🇨🇫Sonio

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2023
US

UltraSight AI Guidance

UltraSight Inc.

Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Multi-modalityWorkflow & image management510(k) 2023
US

syngo.CT Lung CAD (Version VD30)

🇩🇪Siemens Healthcare GmbH

Lung Computed Tomography System, Computer-Aided Detection

Multi-modalityWorkflow & image management510(k) 2023
US

Biograph Vision.X and Biograph Vision.X Edge

🇺🇸Siemens Medical Solutions USA, Inc.

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2023
US

Spine Auto Views

🇫🇷GE Medical Systems SCS

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2023
US

ECHELON Synergy MRI system

🇯🇵FUJIFILM Healthcare Corporation

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2023
US

MOZI TPS

🇨🇳Manteia Technologies Co., Ltd.

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2023
US

HepaFatSmart (V2.0.0)

🇦🇺Resonance Health Analysis Services Pty Ltd

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2023
US

Voluson SWIFT; Voluson SWIFT+

GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2023
US

CAC Software

Imbio, Inc.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2023
US

Sonic DL

GE Medical Systems,LLC (GE Healthcare)

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2023
US

Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite

🇺🇸Ge Medical Systems, LLC

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Multi-modalityWorkflow & image management510(k) 2023
US

Autoplaque

Cedars-Sinai Medical Center: AIM

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2023
US

Radiation Planning Assistant (RPA)

🇺🇸University of Texas, MD Anderson Cancer Center

System, Planning, Radiation Therapy Treatment

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

SubtleMR (2.3.x)

🇺🇸Subtle Medical, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2023
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