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.

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BoneView

🇨🇳Gleamer

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Multi-modalityWorkflow & image management510(k) 2022
US

MAGNETOM Vida with syngo MR XA50A

🇺🇸Siemens Medical Solutions USA, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2022
US

Annalise Enterprise CXR Triage Pneumothorax

🇦🇺Annalise.ai

Lesion detection/diagnosis software

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

Viz ANEURYSM, Viz ANX

🇺🇸Viz.ai, Inc.

Lesion detection/diagnosis software

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

Deep Learning Image Reconstruction

🇺🇸Ge Medical Systems, LLC

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2022
US

Voluson P6, Voluson P8

🇺🇸GE Healthcare

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2022
US

SIGNA Artist Evo

🇨🇳GE Healthcare (Tianjin) Company Limited

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2022
US

Rapid

iSchema View Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2022
US

Micro C Medical Imaging System, M01

🇺🇸OXOS Medical, Inc.

System, X-Ray, Mobile

Multi-modalityWorkflow & image management510(k) 2022
US

Revolution Ascend

🇯🇵Ge Healthcare Japan Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2022
EmergencyUS

syngo.CT Brain Hemorrhage

🇺🇸Siemens Medical Solutions USA, Inc.

Triage & notification (CADt)

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

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5

🇯🇵Canon Medical Systems Corporation

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2022
US

syngo.CT Extended Functionality

🇺🇸Siemens Medical Solutions USA, Inc.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2022
US

SIGNA Hero

GE Healthcare (GE Medical Systems, LLC)

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2022
US

SIGNA Prime

🇨🇳GE Healthcare (Tianjin) Company Limited

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2022
US

Precise Image

🇳🇱Philips Medical Systems Nederland B.V.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2022
US

Eclipse II with Smart Noise Cancellation

🇺🇸Carestream Health, Inc.

Solid State X-Ray Imager (Flat Panel/Digital Imager)

Multi-modalityWorkflow & image management510(k) 2022
US

Quantib ND

Quantib B.V.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2022
US

Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert

🇺🇸GE Healthcare

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2022
US

UNiD Spine Analyzer

MEDICREA International, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2022
US

AIBOLIT 3D+

Aibolit Technologies, LLC

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2022
US

LiverSmart

🇦🇺Resonance Health Analysis Services Pty Ltd

Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

Multi-modalityWorkflow & image management510(k) 2021
US

Koios DS

🇺🇸Koios Medical, Inc.

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Multi-modalityWorkflow & image management510(k) 2021
US

HealthPPT

Zebra Medical Vision Ltd.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2021
US

Al-Rad Companion (Pulmonary)

🇺🇸Siemens Medical Solutions USA, Inc.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2021
US

Cydar EV (Series B) and Cydar EV Maps

🇬🇧Cydar Ltd.

Interventional Fluoroscopic X-Ray System

Multi-modalityWorkflow & image management510(k) 2021
US

Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

🇯🇵Canon Medical Systems Corporation

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2021
US

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

🇺🇸Hyperfine, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2021
US

Soteria.AI

🇺🇸Omega Medical Imaging, LLC

Interventional Fluoroscopic X-Ray System

Multi-modalityWorkflow & image management510(k) 2021
US

TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System

🇨🇳Shenzhen Mindray Bio-Medical Electronics Co.,LTD

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2021
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