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    K Number
    K982112
    Device Name
    THERMATREK IRIS-3 INFRARED IMAGING SYSTEM
    Manufacturer
    THERMATREK, INC.
    Date Cleared
    1998-08-20

    (65 days)

    Product Code
    LHQ
    Regulation Number
    884.2980
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMATREK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IRIS-3 Infrared Imaging System is a thermal camera based imaging device intended for use during coronary bypass surgery. Thermal imaging of the exposed heart, using the IRIS-3, permits the viewing and recording of changes in tissue temperature prior to grafting, cooling of the myocardial, and perfusion of the tissue distal to the anastomosis after grafting. Recording of the temperature difference may be obtained using the videocassette recorder.
    Device Description
    The IRIS-3 Infrared Imaging System is a thermal camera based imaging device.
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