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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROHEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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.
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