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510(k) Data Aggregation

    K Number
    K121448
    Device Name
    ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY
    Manufacturer
    ELEKTA INC. D/B/A NUCLETRON CORPORATION
    Date Cleared
    2012-07-02

    (48 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELEKTA INC. D/B/A NUCLETRON CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.
    Device Description
    The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel. The system is intended for use by qualified medical personnel in radiotherapy clinics, suitably trained by Nucletron staff (or other competent people) in using the system. The Oncentra system should be configured locally and maintained by radiation physicists. It is a requirement that the person responsible for the local configuration has been suitably trained in configuring and maintaining the system. Oncentra 4.2 uses externally acquired medical images and user input. The Oncentra 4.2 software is based on a modular client/server design, with the treatment planning functions divided into "Activities".
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