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

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
US

Clarius Ultrasound Scanner

🇨🇦Clarius Mobile Health Corp.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2021
US

FlightPlan for Liver

🇫🇷GE Medical Systems SCS

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2021
US

SwiftMR

🇰🇷Airs Medical, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2021
US

SubtlePET

🇺🇸Subtle Medical, Inc.

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2021
US

Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System

🇩🇪Philips Medical Systems

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2021
US

Deep Learning Image Reconstruction

🇯🇵Ge Healthcare Japan Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2021
US

Intelligent NR

🇯🇵Canon Inc.

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

Multi-modalityWorkflow & image management510(k) 2021
US

HealthCCSng

Zebra Medical Vision Ltd.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2021
US

Versana Premier

🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2021
US

Aquilion Exceed LB

🇯🇵Canon Medical Systems Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2021
US

HERA W9, HERA W10 Diagnostic Ultrasound System

🇰🇷Samsung Medison Co., Ltd.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2021
US

V8 Diagnostic Ultrasound System

🇰🇷Samsung Medison Co., Ltd.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2021
US

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

🇩🇪Philips Medical Systems

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2021
US

RayStation 11.0

🇸🇪RaySearch Laboratories AB (PUBL)

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2021
US

AI Segmentation

🇺🇸Varian Medical Systems, Inc.

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2021
US

Auto Lung Nodule Detection

🇰🇷Samsung Electronics Co.,Ltd.

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2021
US

EndoNaut

Therenva SAS

Interventional Fluoroscopic X-Ray System

Multi-modalityWorkflow & image management510(k) 2021
US

RBknee

🇩🇰Radiobotics ApS

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2021
US

Discovery MI Gen2

🇺🇸Ge Medical Systems, LLC

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2021
US

TruSPECT Radiological Image Processing Station

🇮🇱Spectrum Dynamics Medical, Ltd.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2021
US

uCT ATLAS with uWS-CT-Dual Energy Analysis

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2021
US

Vereos PET/CT

🇳🇱Philips Medical Systems Nederland B.V.

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2021
US

Kosmos

🇺🇸EchoNous, Inc.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2021
US

syngo.via RT Image Suite

🇺🇸Siemens Medical Solutions USA, Inc.

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2021
US

aPROMISE

🇸🇪EXINI Diagnostics AB

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2021
US

ClariCT.AI

🇰🇷ClariPi Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2021
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