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

syngo.CT CaScoring

🇺🇸Siemens Medical Solutions USA, Inc.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2019
US

QyScore Software

🇫🇷Qynapse

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
US

Deep Learning Image Reconstruction

🇯🇵Ge Healthcare Japan Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2019
US

Icobrain

icometrix NV

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
US

NemoScan

🇪🇸Software Nemotec S.L.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
US

PhantomMSK Trauma

🇺🇸OrthoGrid Systems Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
US

HealthCXR

Zebra Medical Vision Ltd.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2019
US

RSI-MRI+

MultiModal Imaging Services Corporation (dba HealthLytix)

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
US

MEDIP PRO

MEDICALIP Co., Ltd

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
US

Cleerly Labs

🇺🇸Cleerly, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
US

KOALA

🇫🇷IB Lab GmbH

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
US

RTHawk, HeartVista Cardiac Package

HeartVista, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2019
US

Merge PACS

🇺🇸Merge Healthcare Incorporated

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
US

Ventripoint Medical System Plus (VMS+) 3.0

🇨🇦Ventripoint Diagnostics Ltd.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
US

CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)

🇺🇸Omega Medical Imaging, LLC

System, X-Ray, Fluoroscopic, Image-Intensified

Multi-modalityWorkflow & image management510(k) 2019
US

Syngo.Via RT Image Suite

🇺🇸Siemens Medical Solutions USA, Inc.

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2019
US

SubtleMR

🇺🇸Subtle Medical, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
US

SIS Software Version 3.6.0

Surgical Information Sciences, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
US

AI-Rad Companion (Cardiovascular)

🇺🇸Siemens Medical Solutions USA, Inc.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2019
US

D2P

3D Systems, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
US

Clarius Ultrasound Scanner

🇨🇦Clarius Mobile Health Corp.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2019
US

Critical Care Suite

🇺🇸Ge Medical Systems, LLC

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2019
US

aBSI

🇸🇪EXINI Diagnostics AB

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
US

AI-Rad Companion (Pulmonary)

🇺🇸Siemens Medical Solutions USA, Inc.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2019
US

iNtuition-Structural Heart Module

🇺🇸Terarecon,Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
EmergencyUS

DeepCT

Deep01 Limited

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2019
US

RayCare 2.3

🇸🇪RaySearch Laboratories AB (PUBL)

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2019
US

Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE

🇯🇵Canon Medical Systems Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2019
US

Koios DS for Breast

🇺🇸Koios Medical, Inc.

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Multi-modalityWorkflow & image management510(k) 2019
US

LiverMultiScan (LMSv3)

Perspectum Diagnostics Ltd

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2019
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