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

Dose+ (1.0)

🇫🇮Mvision AI Oy

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2025
US

OsteoSight™ Hip (v1)

🇬🇧Naitive Technologies Ltd

Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

Multi-modalityWorkflow & image management510(k) 2025
US

VELMENI for DENTISTS (V4D)

Velmeni Inc.

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2025
US

Sonosite LX and Sonosite PX Ultrasound Systems

🇺🇸Fujifilm Sonosite Inc

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

SurgiTwin

Twinsight

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2025
US

Definium Tempo Select

Ge Hualun Medical Systems Co. , Ltd.

System, X-Ray, Stationary

Multi-modalityWorkflow & image management510(k) 2025
EmergencyUS

Brainomix 360 Triage Stroke

🇬🇧Brainomix Limited

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2025
US

Vista OS, Vista AI Scan, RTHawk

🇺🇸Vista AI, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
EmergencyUS

Methinks CTA Stroke

Methinks Software S.L.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2025
US

ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System

🇺🇸Siemens Medical Solutions USA, Inc.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

uMR Jupiter

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

Revolution Vibe

🇺🇸Ge Medical Systems, LLC

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2025
US

YSIO X.pree

🇩🇪Siemens Medical Solutions

System, X-Ray, Stationary

Multi-modalityWorkflow & image management510(k) 2025
US

Venue; Venue Go; Venue Fit; Venue Sprint

🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

🇺🇸Philips Ultrasound, LLC

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

Neuro Insight V1.0

Olea Medical S.A.S.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2025
US

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR

🇯🇵Canon Medical Systems Corporation

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

GyriCalc (Version 1.0.0)

NeuroSpectrum Insights Corp.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2025
US

V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System

🇰🇷Samsung Medison Co., Ltd.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

uMR Ultra

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2025
US

uMR 680

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
EmergencyUS

Rapid CTA 360

🇺🇸iSchemaView

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2025
US

LUMINOS Q.namix T; LUMINOS Q.namix R

🇩🇪Siemens Medical Solutions

Interventional Fluoroscopic X-Ray System

Multi-modalityWorkflow & image management510(k) 2025
US

Vivid Pioneer

🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

TAVIPILOT

Caranx Medical

Interventional Fluoroscopic X-Ray System

Multi-modalityWorkflow & image management510(k) 2025
US

StrokeSENS ASPECTS Software Application

🇨🇦Circle Cardiovascular Imaging, Inc.

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Multi-modalityWorkflow & image management510(k) 2025
US

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

🇺🇸Philips Ultrasound, LLC

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)

🇮🇹Esaote, S.p.A.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

CardIQ Suite

🇫🇷GE Medical Systems SCS

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2025
NewerPage 4 of 24Older