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510(k) Data Aggregation

    K Number
    K090552
    Device Name
    UROCARE
    Manufacturer
    NEUSOFT MEDICAL SYSTEMS CO., LTD.
    Date Cleared
    2009-03-16

    (14 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K052995,K041521
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The UroCARE1.0 is a soft-copy reading workstation intended for clinical review of CT abdominal (urology) images which allows easy acquisition, transmission and review of the medical images and supports HD ROI (High Density Region of Interest) analysis. Images may be interpreted by a trained physician to obtain information that may be useful in the determination of a diagnosis, except in the case of mammography images.

    Device Description

    UroCARE1.0 software product is a soft-copy reading workstation for clinical review of CT abdominal (urology) images. It is a self-contained software package and provides general features of 2D image display, standard Multi-Planar Reformation (MPR) views and 3D views of Volume Rendering. An additional feature, HD ROI analysis, allows for segmentation of high density regions in terms of user-defined threshold within a user-given ROI as well as display and quantitative analysis of the segmented HD ROI.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the UroCARE1.0, outlining its intended use, description, and substantial equivalence to predicate devices, but lacks the detailed performance study information requested.

    Therefore, I cannot provide the tables and information requested.

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