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510(k) Data Aggregation

    K Number
    K063047
    Device Name
    MEDHOT MTI 2000 THERMAL IMAGING SYSTEM
    Manufacturer
    MEDHOT THERMAL IMAGING, INC.
    Date Cleared
    2006-10-19

    (15 days)

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

    MEDHOT THERMAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for qualified healthcare personnel who are trained in its use, the MedHot MTI 2000 is a non-contact, non-invasive, non-radiating, thermographic imaging device for use as an adjunct to other clinical diagnostic procedures in the capture, quantification, and screening, of differences in skin surface temperature changes. The device can digitally render quantitative images of thermal data via the capture and algorithmic interpretation of relative infrared information from the imaging camera in collaborative use with a compatible computer system which provides a user interface and image storage. Patient populations and environmental use includes all age groups from adult to pediatric and neonatal in hospital, sub acute and public areas i.e. airports.
    Device Description
    The MedHot MTI 2000 thermal imaging system is a non-invasive system that provides the user a visual representation of thermal temperature data in the form of a quantitative image on the users computer screen. The process begins by the cameras' capture of a data array representative of infrared radiation naturally emitted by the object being imaged; the data array is converted to a temperature data array using an algorithmic derivative. Once the infrared data is in the form of temperature data, software on the user's computer is used to generate an image from the rendered temperature data. The user can use this image in a number of ways to quantify the temperature of objects imaged.
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