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

Volpara Imaging Software

Volpara Health Technologies Limited

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2021
US

Chest-CAD

🇺🇸Imagen Technologies, Inc

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2021
US

MAGNETOM Free.Max

🇺🇸Siemens Medical Solutions USA, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2021
US

RayStation 10.1

🇸🇪RaySearch Laboratories AB (PUBL)

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2021
US

Precise Position

🇨🇳Philips Healthcare (Suzhou) Co., Ltd.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2021
US

Qmenta Care Platform Family

Mint Labs, Inc., d/b/a. QMENTA

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2021
US

OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System

🇺🇸Abbott Medical

System, Imaging, Optical Coherence Tomography (Oct)

Multi-modalityWorkflow & image management510(k) 2021
US

Overjet Dental Assist

Overjet, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2021
US

SIGNA 7.0T

🇺🇸Ge Medical Systems, LLC

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2021
US

HS40 Diagnostic Ultrasound System

🇰🇷Samsung Medison Co., Ltd.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2021
US

HYPER AiR

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2021
US

Cartesion Prime (PCD-1000A/3) V10.8

🇯🇵Canon Medical Systems Corporation

System, Tomography, Computed, Emission

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

Eclipse II with Smart Noise Cancellation

🇺🇸Carestream Health, Inc.

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

Multi-modalityWorkflow & image management510(k) 2021
US

SIS System (Version 5.1.0)

Surgical Information Sciences, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2021
US

syngo.CT Lung CAD

🇩🇪Siemens Healthcare GmbH

Lung Computed Tomography System, Computer-Aided Detection

Multi-modalityWorkflow & image management510(k) 2021
US

MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea

🇺🇸Siemens Medical Solutions USA, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2021
US

Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System

🇯🇵Canon Medical Systems Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2021
US

Oncospace

Oncospace, Inc.

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2021
US

Optellum Virtual Nodule Clinic, Optellum software, Optellum platform

🇬🇧Optellum Ltd

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Multi-modalityWorkflow & image management510(k) 2021
US

Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR

🇯🇵Canon Medical Systems Corporation

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2021
US

MaxFOV 2

🇺🇸Ge Medical Systems, LLC

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2021
US

SubtleMR

🇺🇸Subtle Medical, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2021
US

NinesMeasure

Nines, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2021
US

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System

🇨🇦Perimeter Medical Imaging AI, Inc.

System, Imaging, Optical Coherence Tomography (Oct)

Multi-modalityWorkflow & image management510(k) 2021
US

TruPlan

🇨🇦Circle Cardiovascular Imaging, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2021
US

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

🇯🇵Fujifilm Corporation

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2021
US

QUIBIM Precision Prostate (qp-Prostate)

🇪🇸Quibim S.L.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2021
US

Vantage Orian 1.5T, MRT-1550, V6.0

🇯🇵Canon Medical Systems Corporation

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2021
US

Hepatica v1 (Hepatica v1.0.0)

🇬🇧Perspectum, Ltd.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2021
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