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510(k) Data Aggregation

    K Number
    K020320
    Device Name
    RADIOSYSTEM/NT, MODEL 80-13020
    Manufacturer
    STYKER INSTRUMENTS
    Date Cleared
    2002-08-28

    (209 days)

    Product Code
    IYE
    Regulation Number
    892.5050
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    Applicant Name (Manufacturer) :

    STYKER INSTRUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RadioSystem/NT stereotactic planning software is a software-based planning system intended for the creation of treatment plans for radiation therapy with high-energetic photons. It is used for patients which are selected for a precise radiation therapeutical treatment of arbitrary parts of the human body according to medical diagnosis. It may be used only by radiation therapeutical experts under medical supervision in rooms which are suitable for the operation of computers. In addition the planning of interstitial radiosurgery by implanting radioactive seeds inside of the target volume (Brachytherapy) and the planning of stereotactic approaches (Stereotaxy) will be supported.
    Device Description
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