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

SwiftMR

🇰🇷Airs Medical, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2022
EmergencyUS

BriefCase

🇮🇱Aidoc Medical , Ltd.

Triage & notification (CADt)

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

Rapid PE Triage and Notification (PETN)

🇺🇸iSchemaView, Inc.

Triage & notification (CADt)

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

syngo.CT CaScoring

🇺🇸Siemens Medical Solutions USA, Inc.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2022
US

Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems

🇳🇱Philips Medical Systems Nederland B.V.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2022
US

Quantib Prostate

🇳🇱Quantib BV

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2022
US

MAGNETOM Skyra Fit

🇺🇸Siemens Medical Solutions USA, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2022
US

Versana Balance

🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2022
US

Overjet Caries Assist

Overjet, Inc.

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2022
US

Segment 3DPrint

🇸🇪Medviso AB

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2022
US

MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A

🇺🇸Siemens Medical Solutions USA, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2022
US

aPROMISE X

🇸🇪EXINI Diagnostics AB

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2022
US

Philips Incisive CT

🇨🇳Philips Healthcare (Suzhou) Co., Ltd.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2022
EmergencyUS

BriefCase

🇮🇱Aidoc Medical , Ltd.

Triage & notification (CADt)

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

HealthOST

NanoxAI Ltd.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2022
US

Videa Caries Assist

🇺🇸VideaHealth Inc.

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2022
US

RayStation 11B

🇸🇪RaySearch Laboratories AB (PUBL)

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2022
US

Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR

🇯🇵Canon Medical Systems Corporation

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2022
US

INT Contour

🇺🇸Carina Medical LLC

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2022
US

ClariPulmo

🇰🇷ClariPi Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2022
US

HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System

🇰🇷Samsung Medison Co., Ltd.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2022
US

MRCAT Head & Neck

🇫🇮Philips Oy

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2022
US

MAGNETOM Avanto Fit

🇺🇸Siemens Medical Solutions USA, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2022
US

Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5

🇯🇵Canon Medical Systems Corporation

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2022
EmergencyUS

BriefCase

🇮🇱Aidoc Medical , Ltd.

Triage & notification (CADt)

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

BriefCase

🇮🇱Aidoc Medical , Ltd.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2022
US

CardIQ Suite

🇫🇷GE Medical Systems SCS

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2022
US

ClearRead Xray Pneumothorax

Riverain Technologies, Inc.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2022
US

Second Opinion

🇺🇸Pearl, Inc.

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2022
EmergencyNeuro / Head & NeckChest / ThoracicUS + EU

Aidoc BriefCase-Triage

🇮🇱Aidoc

Triage & notification (CADt)

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