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510(k) Data Aggregation

    K Number
    K030165
    Device Name
    THERMATREK IRIS-IV INFRARED IMAGING SYSTEM
    Manufacturer
    Date Cleared
    2003-04-16

    (90 days)

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

    THERMATREK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IRIS-IV Infrared Imaging System is a non-contact, non-invasive, non-radiating, thermal (infrared) imaging device intended for viewing heat patterns generated by the relative surface temperature of human heart tissue and vessels during coronary bypass surgery. Images of the exposed heart may be captured as black and white video images using a digital frame grabber and computer hard-drive. Digitally stored images may then be transferred from the hard-drive to a CD-ROM for portability. The IRIS-IV Infrared Imaging System may be used to perform the viewing and documenting of temperature differences prior to grafting, cooling of the myocardial, and perfusion of the tissue distal to the anastomosis after grafting.
    Device Description
    Not Found
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    K Number
    K982112
    Device Name
    THERMATREK IRIS-3 INFRARED IMAGING SYSTEM
    Manufacturer
    Date Cleared
    1998-08-20

    (65 days)

    Product Code
    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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