AI Devices

Multi-modality AI devices

Radiology AI devices for Multi-modality imaging, FDA-cleared or EU CE-marked, newest clearance first. Information only, never clinical advice.

US

Lumify Diagnostic Ultrasound System

🇺🇸Philips Ultrasound

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2023
EmergencyUS

Rapid SDH

🇺🇸iSchemaView, Inc.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(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
EmergencyUS

EFAI NeuroSuite CT ICH Assessment System

Ever Fortune.Ai, Co., Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(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
EmergencyUS

Brainomix 360 Triage LVO

🇬🇧Brainomix Limited

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2023
US

OFIX MIS App

🇺🇸Orthofix US LLC

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2023
EmergencyUS

Annalise Enterprise CTB Triage Trauma

Annalise-AI Pty Ltd

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2023
US

Jazz

AI Medical AG

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2023
EmergencyUS

Annalise Enterprise CTB Triage Trauma

Annalise-AI Pty Ltd

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(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
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