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510(k) Data Aggregation

    K Number
    K151560
    Device Name
    QuickPlan
    Manufacturer
    Date Cleared
    2015-09-11

    (93 days)

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

    Siris Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The QuickPlan Treatment Planning System is indicated for use in planning radiotherapy treatments for patients with malignant or benign diseases. After image acquisition, QuickPlan supports the treatment planning process for external beam irradiation with photon, electron, and proton beams by predicting a plan. The QuickPlan software does not provide full plan generation; it does not include final dose calculation, final beam geometry, nor does it enable plan approval. QuickPlan is not connected to any radiation emitting equipment. The QuickPlan software is intended for use by trained medical professionals to use in clinical settings. The QuickPlan software is compatible with Treatment Planning Systems that use the DICOM-RT format.
    Device Description
    The new QUICKPLAN Software manufactured by Siris Medical is an independent software solution to plan radiotherapy treatments for patients with malignant or benign diseases. It is used to plan external beam irradiation with photon, electron, and proton beams. The new QUICKPLAN Software is intended for trained medical professionals to use in clinical settings. The new QUICKPLAN software application includes three modules: - QuickMatch Matches a critical structure-set to the closest match within a database. It is a rapid file locator. - QuickPredict Predicts the dose to critical structures based upon models extracted from historical data looking through previous patient data. - QuickCompare - Provides dose estimates to critical structures with one or more alternative energy modalities, i.e. Photon vs. Proton. The new QuickPlan software does not provide full plan generation; it does not include final dose calculation, final beam geometry, nor does it enable plan approval.
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