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510(k) Data Aggregation

    K Number
    K250045
    Device Name
    uWS-Angio Pro
    Manufacturer
    Shanghai United Imaging Healthcare Co., Ltd.
    Date Cleared
    2025-09-24

    (257 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K142273,K233209,K230955
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K142273, K233209

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The uWS-Angio Pro is a post-processing software based on the uWS-Angio Basic for viewing, processing, evaluating and analyzing CT, MR, 3D XA images, and overlaying 2D medical images to support image guidance during interventional procedures. It has the following application:

    The uWS-Angio Pro uTarget view application is intended to provide tools for adding the trajectory to the lesion. It also supports overlay of 3D datasets on 2D fluoroscopy images.

    The uWS-Angio Pro uEmbo View application is intended to provide users with tools for planning and guiding interventional procedures. It offers a suite of features to mark targets, detect feeder vessels, and overlay the 3D image with the feeders and the corresponding anatomical X-ray image. When the overlay function is activated, it supports automatic 2D-3D image registration specifically for head neuroimaging, while the manual registration function is not restricted to any specific anatomical region.

    The uWS-Angio Pro uCardiac View application is intended to provide users tools to plan and guide the interventional procedures. This application can use CT angiography images for vascular access analysis, aortic root analysis and angle management, and overlay registration display with 2D XA images.

    Device Description

    uWS-Angio Pro is a software intended for viewing, processing, evaluating and analyzing medical images that comply with the DICOM 3.0 protocol. It supports interpretation and evaluation of examinations within healthcare institutions. It can be deployed on independent hardware such as a stand-alone diagnostic review and post-processing workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, it can be deployed on systems of the United Imaging Healthcare Angiography system family.

    uWS-Angio Pro contains the following applications:

    • uWS-Angio Pro uTarget View
    • uWS-Angio Pro uEmbo View
    • uWS-Angio Pro uCardiac View
    AI/ML Overview

    N/A

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