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510(k) Data Aggregation

    K Number
    K963730
    Device Name
    PROTEC (1024)
    Date Cleared
    1997-02-10

    (147 days)

    Product Code
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROPORTIONAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    imaging human organs through use of injected radiopharmaceuticals, which are separately regulated as diagnostic drugs. The device will have a wide variety of applications in planar single organ and whole body imaging.
    Device Description
    The Protec-1024 is an imaging device utilized to determine the distribution of gammaemitting radioactive tracers within the human body. The device consists of a radiation detection head, containing a multiwire proportional detector, coupled to a mobile part, containing electronics utilized to process images from the detector, and a computer utilized to control image acquisition and to provide image processing and display.
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