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510(k) Data Aggregation

    K Number
    K970598
    Device Name
    INTEGRATED VISUALIZATION SYSTEM
    Manufacturer
    UROHEALTH, INC.
    Date Cleared
    1997-03-12

    (22 days)

    Product Code
    FCW
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K951647,K963046
    Why did this record match?
    Reference Devices :

    K951647, K963046

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

    The IVS is used in providing illumination for endoscopic procedures and transmitting an image from an endoscope to a viewing monitor, which is integral to the system.

    Device Description

    The Integrated Visualization System is comprised of a light source, CCD camera, and 10.4" flat panel monitor, all housed in a single unit weighing approximately seven pounds. It has an immersible camera head with minimum illumination requirements of 1 lux. The light source uses 24 watts and outputs a color temperature of 5460°K.

    AI/ML Overview

    This 510(k) notification describes an "Integrated Visualization System" which is a light source, camera, and a monitor in one unit. This device is a medical apparatus designed to provide illumination and image transmission for endoscopic procedures. It is not an AI/ML device, and thus the requested information (acceptance criteria, study details, expert involvement, ground truth, training data, etc.) is not applicable in the context of AI/ML device evaluation. The document focuses on performance specifications (like light output, camera illumination requirements) and comparisons to predicate devices in terms of its technical function, not its diagnostic accuracy or AI performance.

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