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

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage

🇰🇷Vuno Inc.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2024
US

The 5000 Compact Series Ultrasound Systems

🇺🇸Philips Ultrasound, LLC

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

1CMR Pro

Mycardium AI Limited

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2024
US

Fetal EchoScan

🇫🇷Brightheart

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Multi-modalityWorkflow & image management510(k) 2024
EmergencyUS

NeuroICH

🇺🇸Neurocareai Inc.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2024
US

icobrain aria

icometrix NV

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Multi-modalityWorkflow & image management510(k) 2024
US

nordicMEDiVA

🇳🇴NordicNeurolab AS

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2024
EmergencyUS

BriefCase-Triage

🇮🇱Aidoc Medical , Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2024
US

SIGNA MAGNUS

🇺🇸Ge Medical Systems, LLC

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2024
US

HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System

🇰🇷Samsung Medison Co., Ltd.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

EPIQ Series Diagnostic Ultrasound System

🇺🇸Philips Ultrasound, LLC

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

SpineUs™ System

🇺🇸Verdure Imaging

System, Imaging, Pulsed Echo, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

EchoSolv AS

Echo IQ Ltd

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Multi-modalityWorkflow & image management510(k) 2024
US

Versana Premier; Versana Premier Lotus; LOGIQ F

🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

MuscleView

Springbok, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2024
US

CAC (gated) Algorithm

🇺🇸BunkerHill Health

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2024
EmergencyUS

JBS-LVO

🇰🇷JLK, Inc.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2024
EmergencyUS

uAI Easy Triage ICH

Shanghai United Imaging Intelligence Co., Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2024
US

MAMMOMAT B.brilliant with Tomosynthesis Option

🇺🇸Siemens Medical Solutions USA, Inc.

Digital Breast Tomosynthesis

Multi-modalityWorkflow & image managementPMA 2024
EmergencyUS

CINA-CSpine

🇫🇷Avicenna.AI

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2024
US

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)

🇯🇵Canon Medical Systems Corporation

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

FETOLY-HEART

🇫🇷Diagnoly

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

TRAQinform IQ

AIQ Global, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2024
US

Velacur

🇨🇦Sonic Incytes

System, Imaging, Pulsed Echo, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

Velmeni for Dentists (V4D)

Velmeni Inc.

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2024
US

uMI Panorama

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2024
US

Kosmos

🇺🇸EchoNous, Inc.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

AiMIFY (1.x)

🇺🇸Subtle Medical, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2024
US

Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR

🇯🇵Canon Medical Systems Corporation

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2024
US

HealthCCSng

🇮🇱Nano-X AI Ltd.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2024
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