AI Devices

Workflow & image management

Radiology AI devices in the Workflow & image management category, FDA-cleared or EU CE-marked, newest clearance first. Information only, never clinical advice.

US

iNtuition-Structural Heart Module

🇺🇸Terarecon,Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(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
US

RayStation

🇸🇪RaySearch Laboratories AB (PUBL)

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2019
US

ClariCT.AI

🇰🇷ClariPi Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
US

Aquilion ONE (TSX-305A/6) V8.9 with AiCE

🇯🇵Canon Medical Systems Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2019
US

SurgicalAR

🇺🇸MEDIVIS, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
US

Lung Vision System

🇮🇱Body Vision Medical Ltd.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
US

Deep Learning Image Reconstruction

🇺🇸Ge Medical Systems, LLC

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2019
US

Bone VCAR (BVCAR)

🇫🇷GE Medical Systems SCS

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2019
US

SIS Software version 3.3.0

Surgical Information Sciences, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
US

AI Rad Companion (Engine)

🇺🇸Siemens Medical Solutions USA, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
US

SIGNA Premier

🇺🇸Ge Medical Systems, LLC

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2019
US

MRCP+ v1.0

Perspectum Diagnostics Ltd

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2019
US

AmCAD-UO

🇹🇼AmCad BioMed Corporation

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2018
US

Quantib ND

🇳🇱Quantib BV

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2018
US

iSchemaView RAPID

🇺🇸iSchemaView, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2018
US

vascuCAP

Elucid Bioimaging Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2018
US

Centricity Universal Viewer

🇺🇸GE Healthcare

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2018
US

AMRA Profiler

🇸🇪AMRA Medical AB

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2018
US

FerriSmart Analysis System

🇦🇺Resonance Health Analysis Services Pty Ltd

Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

Multi-modalityWorkflow & image management510(k) 2018
US

SubtlePET

🇺🇸Subtle Medical, Inc.

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2018
US

Vitrea CT Brain Perfusion

Vital Images, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2018
US

icobrain

icometrix NV

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2018
US

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System

NinePoint Medical, Inc.

System, Imaging, Optical Coherence Tomography (Oct)

Multi-modalityWorkflow & image management510(k) 2018
US

Vivid E80, Vivid E90, Vivid E95

🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2018
US

Arterys MICA

🇺🇸Arterys, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2018
US

Ziostation2

🇯🇵Ziosoft, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2018
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