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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Synapse 3D, Synapse 3D Base Tools v6.1

🇯🇵Fujifilm Corporation

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2021
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QUIBIM Precision Prostate (qp-Prostate)

🇪🇸Quibim S.L.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2021
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Vantage Orian 1.5T, MRT-1550, V6.0

🇯🇵Canon Medical Systems Corporation

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2021
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uAI EasyTriage-Rib

Shanghai United Imaging Intelligence Co., Ltd.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2021
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Hepatica v1 (Hepatica v1.0.0)

🇬🇧Perspectum, Ltd.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2021
US

Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i

🇯🇵Canon Medical Systems Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2021
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Imagio Breast Imaging System

🇺🇸Seno Medical Instruments, Inc.

Optoacoustic Imaging System

Multi-modalityWorkflow & image managementPMA 2021
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BrainInsight

Hyperfine Research, Inc

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2021
EmergencyUS

BriefCase

🇮🇱Aidoc Medical , Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2020
US

AI Metrics

AI Metrics, LLC

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
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EchoGo Pro

🇬🇧Ultromics Ltd

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Multi-modalityWorkflow & image management510(k) 2020
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Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I

🇯🇵Canon Medical Systems Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2020
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Deep Learning Image Reconstruction for Gemstone Spectral Imaging

🇺🇸Ge Medical Systems, LLC

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2020
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HepaFat-AI

🇦🇺Resonance Health Analysis Services Pty Ltd

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2020
US

HealthJOINT

Zebra Medical Vision Ltd.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
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Revolution Ascend

🇯🇵Ge Healthcare Japan Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2020
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CorInsights MRI

ADM Diagnostics, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
EmergencyUS

HALO

🇳🇱NICo-Lab B.V.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2020
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PROView

🇫🇷GE Medical Systems SCS

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
US

FastStroke, CT Perfusion 4D

🇫🇷GE Medical Systems SCS

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2020
US

Neuro.Al Algorithm

🇺🇸Terarecon,Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
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A View LCS

🇰🇷Coreline Soft Co.,Ltd

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
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SIGNA 7.0T

🇺🇸Ge Medical Systems, LLC

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2020
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Quantib Prostate

🇳🇱Quantib BV

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
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Cleerly Labs v2.0

🇺🇸Cleerly, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
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LiverMultiScan

🇬🇧Perspectum, Ltd.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2020
US

THINQ

CorticoMetrics LLC

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
US

Xeleris V Processing and Review Systems

🇺🇸GE Healthcare

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
US

RayStation

🇸🇪RaySearch Laboratories AB (PUBL)

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2020
US

Caption Guidance

Caption Health

Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Multi-modalityWorkflow & image management510(k) 2020
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