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    K Number
    K141136
    Device Name
    LEICA FL800
    Manufacturer
    LEICA BIOSYSTEMS RICHMOND
    Date Cleared
    2014-08-19

    (110 days)

    Product Code
    IZI
    Regulation Number
    892.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEICA BIOSYSTEMS RICHMOND

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Leica FL800 is a Leica Surgical Microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area and bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during plastic and reconstructive surgery.
    Device Description
    The Leica FL800 device is an accessory to the Leica surgical microscopes. It allows the surgical microscope to produce excitation light and resolve fluorescence light from the fluorescent agent ICG. The generated fluorescence signal depicts the distribution of the infra-red dye in the patient's blood vessels during the operation (fluorescence video angiography).
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