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510(k) Data Aggregation

    K Number
    K073581
    Device Name
    ICI P AND S SERIES IR CAMERAS
    Manufacturer
    TEXAS INFRARED
    Date Cleared
    2008-07-11

    (204 days)

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

    TEXAS INFRARED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ICI Series P and S IR Cameras, which provides capture of skin surface temperature of any part of the body, and the IR Flash Software version 1.0, which provides visualization and reporting functionalities, are intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature. Environment of use: hospitals, sub-acute healthcare settings, public areas, i.e., airports.
    Device Description
    The ICI Series P and S IR Cameras, which provides capture of skin surface temperature of any part of the body, and the IR Flash Software version 1.0, which provides visualization and reporting functionalities, are intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature. Environment of use: hospitals, sub-acute healthcare settings, public areas, i.e., airport. Components of the system include: ICI P or S Series IR Camera, USB Cable, Tripp-Lite model IS250HG isolation transformer.
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