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

Deep Learning Image Reconstruction

🇯🇵Ge Healthcare Japan Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2023
US

Quantib Prostate

🇳🇱Quantib BV

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2023
US

Ezra Flash

🇺🇸Ezra AI, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2023
US

Ultrasound System 2300

🇫🇷BK Medical Aps

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2023
US

Limbus Contour

Limbus AI Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2023
US

AI-Rad Companion (Cardiovascular)

Siemens Medical Solutions U.S.A.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2023
US

Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems

🇳🇱Philips Medical Systems Nederland B.V.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2023
EmergencyUS

Annalise Enterprise CTB Triage Trauma

Annalise-AI Pty Ltd

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2023
US

Butterfly iQ/iQ+ Ultrasound System

🇺🇸Butterfly Network, Inc.

System, Imaging, Pulsed Echo, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2023
US

RayStation 12A

🇸🇪RaySearch Laboratories AB (PUBL)

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2023
US

DTX Studio Clinic 3.0

🇸🇪Nobel Biocare AB

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2023
US

Annalise Enterprise CXR Triage Trauma

Annalise-AI Pty Ltd

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2023
US

Annalise Enterprise CXR Triage Trauma

Annalise-AI Pty Ltd

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2023
US

MAGNETOM Amira; MAGNETOM Sempra

🇺🇸Siemens Medical Solutions USA, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2023
US

Overjet Caries Assist

Overjet, Inc.

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2023
US

FlightPlan for Embolization

🇫🇷GE Medical Systems SCS

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2023
US

Viz AAA

🇺🇸Viz.ai, Inc.

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2023
US

uMI Panorama

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2023
US

Spectral Bone Marrow

🇺🇸Ge Medical Systems, LLC

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2023
US

Aquilion Precision (TSX-304A/4) V10.14 with AiCE

🇯🇵Canon Medical Systems Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2023
US

Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

🇯🇵Canon Medical Systems Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2023
US

BoneView

🇨🇳Gleamer

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Multi-modalityWorkflow & image management510(k) 2023
EmergencyUS

Rapid NCCT Stroke

🇺🇸iSchemaView, Inc.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2023
US

Xeleris V Processing and Review System

🇺🇸GE Healthcare

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2023
US

Caption Interpretation Automated Ejection Fraction Software

Caption Health, Inc.

Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

Multi-modalityWorkflow & image managementDe Novo 2023
US

AVIEW Lung Nodule CAD

🇰🇷Coreline Soft Co.,Ltd

Lung Computed Tomography System, Computer-Aided Detection

Multi-modalityWorkflow & image management510(k) 2023
US

Brainomix 360 e-ASPECTS

🇬🇧Brainomix Limited

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Multi-modalityWorkflow & image management510(k) 2023
US

Swoop® Portable MR Imaging System™

🇺🇸Hyperfine, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2023
US

uCT ATLAS Astound with uWS-CT-Dual Energy Analysis

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2023
US

uMR 680

Shanghai United Imaging Intelligence Co., Ltd.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2023
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