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    K Number
    K964607
    Device Name
    THERATON 1000E
    Manufacturer
    THERATRONICS, INC.
    Date Cleared
    1997-05-28

    (191 days)

    Product Code
    IWD
    Regulation Number
    892.5750
    Why did this record match?
    Product Code :

    IWD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Cobalt Teletherapy unit is a device by which gamma radiation is delivered for the treatment of cancer under the direction of health care professionals in a radiation therapy clinic.
    Device Description
    The Theratron 1000E consists of a source head, collimator, gantry, main frame, base, controls and a pendulum or beamstopper style counterweight. The design of this device is similar as the predicate device Theratron 1000 with improved safety features and radiation shielding in the collimator area of the unit head assembly.
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