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510(k) Data Aggregation

    K Number
    K982442
    Device Name
    C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)
    Manufacturer
    CARE WISE MEDICAL PRODUCTS CORP.
    Date Cleared
    1998-08-25

    (42 days)

    Product Code
    IZD
    Regulation Number
    892.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARE WISE MEDICAL PRODUCTS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the device here in question, i.e. the Care Wise C-Trak Automatic Analyzer, remains unchanged from the intended use of prior predicate Care Wise and other portable radioisotope detectors. The Care Wise C-Trak Automatic Analyzer is designed- as are all similar devices - to detect and quantify nuclear radiation. It is indicated for external and intraoperative detection of radioactivity in body tissues or organs, such as bowel, bone, lymphatics, and red blood cells, where radiopharmaceuticals are administered.
    Device Description
    The Care Wise C-Trak Automatic Analyzer consists of a battery-powered analyzer designed to operate a hand held probe, display the data from the detected radiation, and display and control the system's operating parameters.
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