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510(k) Data Aggregation

    K Number
    K023434
    Device Name
    DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM
    Manufacturer
    DOREX, INC.
    Date Cleared
    2002-11-14

    (30 days)

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

    DOREX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Thermal Imaging is a noninvasive diagnostic technique that allows a practitioner to quantify and visualize skin surface temperature changes. The Spectrum 9000 MB allows the user to graphically map the body temperature and display the image on a monitor. The Spectrum 9000MB will be used as an aid for diagnosis as well as to follow up therapy on such areas as orthopedics, pain management, neurology and diabetic foot care. The intended use for the Spectrum 9000 MB is similar to what is being used currently on the Dorex DTI-16 thermal imager. Images are captured and stored on a computer that can be used to diagnose problem areas.
    Device Description
    Not Found
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