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510(k) Data Aggregation

    K Number
    K053485
    Device Name
    THERATRON EQUINOX, MODELS 80 CM AND 100 CM
    Manufacturer
    MDS NORDION INC.
    Date Cleared
    2006-03-09

    (84 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    MDS NORDION INC.

    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 Equinox consists of a source head, collimator, gantry, main frame, base, controls and a pendulum or beam-stopper style counterweight. The design of this device is similar to predicate device Theratron Elite 80 and 100.
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