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510(k) Data Aggregation

    K Number
    K171928
    Device Name
    Med-Hot Thermal Imaging Systems
    Manufacturer
    Med-Hot Thermal Imaging Inc.
    Date Cleared
    2017-12-08

    (164 days)

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

    Med-Hot Thermal Imaging Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Med-Hot Thermal Imaging Systems are intended to review, measure and record skin temperature patterns and variations emitted from the human body. They are intended for use as adjunctive diagnostic imaging for thermally significant indications in the regions of the head and neck, breast, chest, abdomen, back and extremities. The value of the value of these thermal patterns is determined by professional investigation. This device is intended for use by qualified technical personnel trained in its use.
    Device Description
    The Med-Hot Thermal Imaging Systems are non-contact infrared imaging devices, with all functions controlled at the computer screen. TotalVision is a patented, clinical personnel friendly software application, validated in the field. The system is delivered with a computer including installed and tested software. The Med-Hot Thermal Imaging camera is suitable for high quality imaging of the human body. The TotalVision Capture Software allows for incoming image data from the camera head and configures that data in a form that can be displayed on the computer screen. This display will include an image of the scene within the camera's field of view allowing the user to visualize thermal patterns or analyze the image in terms relative temperature values. The software makes no determination regarding what the thermal patterns or relative temperature values mean. It will be left to the user to infer areas of interest based on his/her visual interpretation of those patterns or values. The new device consists of: 1. Infrared Camera (MAX 076 320 x 240 array detector or MAX 307 640 x 480 array detector), 2. TotalVision Software, 3. Laptop or desktop computer.
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