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510(k) Data Aggregation

    K Number
    K250040

    Validate with FDA (Live)

    Device Name
    uWS-Angio
    Manufacturer
    Shanghai United Imaging Healthcare Co., Ltd.
    Date Cleared
    2025-09-12

    (247 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K131299,K233186,K230955
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K131299, K233186

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

    uWS-Angio is a post-processing software based on the uWS-Angio Basic for viewing, processing, evaluating and analyzing XA images. It has the following application:

    • The uWS-Angio 2D Vessel Analysis is intended to provide users a tool for quantifying the dimensions of coronary and peripheral vessels from 2D angiographic images. It supports vessel segmentation and output associated diameter parameters and curves.

    • The uWS-Angio Left Ventricular Analysis application is intended to provide users a tool for analyzing left ventricular functions. It supports editing contours of ventricular and outputs a set of parameters to show the ventricular functions and wall motion.

    • The uWS-Angio 2D Blood Flow Analysis application is intended to provide users a tool for analyzing blood flow of region of interest in peripheral vessels. It supports adding interest region and output multiple blood flow parameters for further perfusion analysis.

    • The uWS-Angio Stitching is intended to provide users a tool for lower extremities stitching bolus-chase acquired images into a stitching image.

    Device Description

    uWS-Angio is a post-processing 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 contains the following applications:

    • uWS-Angio 2D Vessel Analysis
    • uWS-Angio Left Ventricular Analysis
    • uWS-Angio 2D Blood Flow Analysis
    • uWS-Angio Stitching
    AI/ML Overview

    N/A

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