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

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 AVC

🇺🇸BunkerHill Health

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2025
US

Prenuvo Body Composition

🇺🇸Prenuvo

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

TechCare Trauma

🇫🇷Milvue

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Multi-modalityWorkflow & image management510(k) 2025
US

Digital Color Doppler Ultrasound System (P60 Series)

🇨🇳Sonoscape Medical Corp.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

Second Opinion CC

🇺🇸Pearl, Inc.

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2025
US

Cardiac Guidance

Caption Health, Inc.

Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Multi-modalityWorkflow & image management510(k) 2025
US

uCT 550

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, X-Ray, Tomography, Computed

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

ScreenDx

Imvaria, Inc.

Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

Multi-modalityWorkflow & image management510(k) 2025
US

Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR

🇯🇵Canon Medical Systems Corporation

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

uCT 780

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2025
US

Soteria E-View

🇺🇸Omega Medical Imaging, LLC

System, X-Ray, Fluoroscopic, Image-Intensified

Multi-modalityWorkflow & image management510(k) 2025
US

Brainomix 360 e-CTA

🇬🇧Brainomix Limited

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2025
US

Clarify DL

🇮🇱GE Medical Systems Israel, Functional Imaging

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2025
EmergencyUS

JLK-ICH

🇰🇷JLK, Inc.

Triage & notification (CADt)

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

Aquilion ONE (TSX-308A/3) V1.5

🇯🇵Canon Medical Systems Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2024
US

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

Lightning Viewer

Nexsys Electronics Inc. dba Medweb

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2024
US

IQ-UIP

Imbio, Inc.

Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

Multi-modalityWorkflow & image management510(k) 2024
US

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

🇺🇸Philips Ultrasound, LLC

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2024
US

BriefCase-Triage

🇮🇱Aidoc Medical , Ltd.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2024
US

V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System

🇰🇷Samsung Medison Co., Ltd.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
EmergencyUS

EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)

Ever Fortune.Ai, Co., Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2024
US

PeekMed web

🇵🇹Peek Health, S.A.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2024
US

ClearRead CT CAC

Riverain Technologies, Inc.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2024
US

HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System

🇰🇷Samsung Medison Co., Ltd.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System

🇺🇸Siemens Medical Solutions USA, Inc.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

Koios DS

🇺🇸Koios Medical, Inc.

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Multi-modalityWorkflow & image management510(k) 2024
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