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

uMI Panvivo

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2024
US

ECHELON Synergy MRI System

🇯🇵FUJIFILM Healthcare Corporation

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2024
US

Omni Legend

🇮🇱GE Medical Systems Israel, Functional Imaging

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2024
US

AISAP Cardio V1.0

🇮🇱Aisap

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Multi-modalityWorkflow & image management510(k) 2024
US

CardIQ Suite

🇫🇷GE Medical Systems SCS

System, X-Ray, Tomography, Computed

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

Rayvolve

🇫🇷AZmed SAS

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Multi-modalityWorkflow & image management510(k) 2024
US

MICSI-RMT

🇺🇸Microstructure Imaging, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2024
US

Swoop® Portable MR Imaging® System

🇺🇸Hyperfine, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2024
EmergencyUS

BriefCase-Triage

🇮🇱Aidoc Medical , Ltd.

Triage & notification (CADt)

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

Hyper Insight - ICH

🇰🇷SK Inc.

Triage & notification (CADt)

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

V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System

🇰🇷Samsung Medison Co., Ltd.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

O-arm O2 Imaging System

🇺🇸Medtronic Navigation, Inc

Interventional Fluoroscopic X-Ray System

Multi-modalityWorkflow & image management510(k) 2024
US

Clarius OB AI

🇨🇦Clarius Mobile Health Corp.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

Radiography 7300 C

🇩🇪Philips Medical Systems DMC GmbH

System, X-Ray, Stationary

Multi-modalityWorkflow & image management510(k) 2024
US

RS85 Diagnostic Ultrasound System

🇰🇷Samsung Medison Co., Ltd.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

CINA-VCF

🇫🇷Avicenna.AI

Lesion detection/diagnosis software

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

uPMR 790

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Multi-modalityWorkflow & image management510(k) 2024
US

Syngo Carbon Enterprise Access (VA40A)

🇩🇪Siemens Healthcare GmbH

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2024
US

VinDr-Mammo

VinBigData Joint Stock Company

Lesion detection/diagnosis software

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

YSIO X.pree

🇩🇪Siemens Medical Solutions

System, X-Ray, Stationary

Multi-modalityWorkflow & image management510(k) 2024
EmergencyUS

Heuron ICH

🇰🇷Heuron Co., Ltd.

Triage & notification (CADt)

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

SmartChest

🇫🇷Milvue

Lesion detection/diagnosis software

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

ECHELON Synergy V10.0

🇺🇸FUJIFILM Healthcare Americas Corporation

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2024
US

CT 5300

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

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2024
US

Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)

🇺🇸Varian Medical Systems, Inc.

Accelerator, Linear, Medical

Multi-modalityWorkflow & image management510(k) 2024
US

syngo.via RT Image Suite

🇺🇸Siemens Medical Solutions USA, Inc.

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2024
US

Sonio Detect

🇨🇫Sonio

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

uMR Jupiter

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2024
US

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

🇺🇸Philips Ultrasound, LLC

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
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