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.

US

RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT

🇩🇪Brainlab AG

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2025
US

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

🇨🇳Siemens Shenzhen Magnetic Resonance , Ltd.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile

🇩🇪Siemens Healthcare GmbH

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
EmergencyUS

Methinks NCCT Stroke

Methinks Software S.L.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2025
US

Second Opinion® CS

🇺🇸Pearl, Inc.

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2025
US

Aurora

🇮🇱GE Medical Systems Israel

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2025
US

Sonic DL

🇺🇸Ge Medical Systems, LLC

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System

🇳🇱Philips Medical Systems Nederland B.V.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

Swoop® Portable MR Imaging® System (V2)

🇺🇸Hyperfine, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

Allix5

🇺🇸Clairity, Inc.

Radiological Software Device To Predict Future Breast Cancer Risk

Multi-modalityWorkflow & image managementDe Novo 2025
EmergencyUS

BriefCase-Triage

🇮🇱Aidoc Medical , Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2025
US

Voluson™ Performance 16; Voluson™ Performance 18

🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

Accuro 3S

🇺🇸Rivanna Medical, Inc.

System, Imaging, Pulsed Echo, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

DEEPECHO

DeepEcho

System, Imaging, Pulsed Doppler, Ultrasonic

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

uMR Omega

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
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

Annalise Enterprise

🇦🇺Annalise.ai

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2025
US

VersaViewer

🇫🇷GE Medical Systems SCS

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2025
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