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

Swoop® Portable MR Imaging® System

🇺🇸Hyperfine, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

SCENARIA View Phase 5.0

🇯🇵Fujifilm Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2025
US

uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2025
US

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)

🇮🇹Esaote, S.p.A.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

InferRead Lung CT.AI

🇨🇳Infervision Medical Technology Co., Ltd.

Lung Computed Tomography System, Computer-Aided Detection

Multi-modalityWorkflow & image management510(k) 2025
US

Smile Dx®

Cube Click, Inc.

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2025
US

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

🇺🇸Philips Ultrasound, LLC

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

Second Opinion® Pediatric

🇺🇸Pearl, Inc.

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2025
US

Fetal EchoScan (v1.1)

🇫🇷Brightheart

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Multi-modalityWorkflow & image management510(k) 2025
US

Vscan Air

🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

uAngio AVIVA CX

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

Interventional Fluoroscopic X-Ray System

Multi-modalityWorkflow & image management510(k) 2025
US

Lung AI (LAI001)

Exo Inc

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2025
US

VersaViewer

🇫🇷GE Medical Systems SCS

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2025
US

SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option

🇮🇱Arineta Ltd.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2025
US

Oncospace

Oncospace, Inc.

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2025
US

Second Opinion Periapical Radiolucency Contours

🇺🇸Pearl, Inc.

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2025
US

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

🇺🇸Philips Ultrasound, LLC

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

BunkerHill BMD

🇺🇸BunkerHill Health

Densitometer, Bone

Multi-modalityWorkflow & image management510(k) 2025
US

HeartFocus (V.1.1.1)

🇫🇷Deski

Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Multi-modalityWorkflow & image management510(k) 2025
US

RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3

🇸🇪RaySearch Laboratories AB (PUBL)

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2025
US

QFR (3.0)

🇳🇱QFR Solutions bv

X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

Multi-modalityWorkflow & image management510(k) 2025
US

V5med Lung AI

V5med Inc.

Lung Computed Tomography System, Computer-Aided Detection

Multi-modalityWorkflow & image management510(k) 2025
US

Rayvolve LN

🇺🇸AZmed

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2025
US

brAIn™ Shoulder Positioning

🇺🇸Avatar Medical

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2025
US

SIGNA Prime Elite

🇺🇸Ge Medical Systems, LLC

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

Better Diagnostics Caries Assist (BDCA) Version 1.0

🇺🇸Better Diagnostics AI Corp

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2025
US

ChestView US

Gleamer SAS

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2025
US

aiCockpit AI Viewer

🇺🇸Fovia, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2025
US

3DXR

🇫🇷GE Medical Systems SCS

Interventional Fluoroscopic X-Ray System

Multi-modalityWorkflow & image management510(k) 2025
US

ART-Plan+ (v.3.0.0)

Therapanacea Sas

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2025
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