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    K Number
    K983436
    Device Name
    GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM
    Manufacturer
    GAMMAMED USA
    Date Cleared
    1998-10-29

    (30 days)

    Product Code
    JAQ
    Regulation Number
    892.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    GAMMAMED USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the GammaMed Plus transportable high-dose-rate remotely controlled afterloading brachytherapy device is for the treatment of cancer by intracavitary, interstitial, intralumenal and intraoperative irradiation.
    Device Description
    The GammaMed Plus is a transportable high-dose-rate remotely controlled afterloading brachytherapy device. The unit is designed to provide a predetermined dose of radiation to tissues and organs by means of manipulating a radioactive source from a shielded position within the device into an applicator, which has been previously placed within or on a patient. The GammaMed plus system is based on a further development of the existing GammaMed 12it system. The GammaMed plus system consists of the following components: Treatment device including computer and control software, Applicators and accessories, Treatment planning system.
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