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510(k) Data Aggregation

    K Number
    K973441
    Device Name
    LEKSELL GAMMAPLAN
    Manufacturer
    PATTERSON CONSULTING GROUP, INC.
    Date Cleared
    1998-04-01

    (202 days)

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

    PATTERSON CONSULTING GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Leksell GammaPlan (LGP) is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument, AB. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health care professionals (Neurosurgeons, Radiation Therapists, Radiation Physicists) such that the desired radiation dose is provided by the Leksell Gamma Knife to a precisely defined target area within the cranium.
    Device Description
    The Leksell GammaPlan® is a computer based dose planning system specifically designed for use with the Leksell Gamma Knife. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. Digital images from CT or MR scanners, or angiograms are imported and processed for treatment planning. Patient treatment protocols are based on single or multiple targets and alternative treatment plans can be generated by the GammaPlan.
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