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510(k) Data Aggregation

    K Number
    K981805
    Device Name
    POS T-7000
    Manufacturer
    POS TECHNOLOGIES, INC.
    Date Cleared
    1998-08-07

    (78 days)

    Product Code
    HCS
    Regulation Number
    882.1570
    Why did this record match?
    Product Code :

    HCS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To measure bilateral differences in skin temperature along the spine
    Device Description
    Not Found
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    K Number
    K974208
    Device Name
    TYTRON C-3000
    Manufacturer
    TITRONICS RESEARCH & DEVELOPMENT CO.
    Date Cleared
    1998-02-03

    (85 days)

    Product Code
    HCS
    Regulation Number
    882.1570
    Why did this record match?
    Product Code :

    HCS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TyTron C-3000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by professional health care providers. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care.
    Device Description
    The TyTron C-3000 is a hand held paraspinal thermographic scanning system. It consists of two probes which each contain infrared sensors designed to be placed on either side of the spinal column to detect temperatures. With the aid of a computer assisted program the system is capable of recording and graphing thermal differentials (right to left thermal asymmetries) on a horizontal scale. It also records direct temperatures on the vertical scale.
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