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510(k) Data Aggregation

    K Number
    K222728
    Device Name
    Radiation Planning Assistant (RPA)
    Manufacturer
    University of Texas, MD Anderson Cancer Center
    Date Cleared
    2023-05-17

    (251 days)

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

    University of Texas, MD Anderson Cancer Center

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Radiation Planning Assistant (RPA) is used to plan radiotherapy treatments with cancers of the head and neck, cervix, breast, and metastases to the brain. The RPA is used to plan external beam irradiation with photon beams using CT images. The RPA is used to create contours and treatment plans that the user imports into their own Treatment Planning System (TPS) for review, editing, and re-calculation of the dose. Some functions of the RPA use Eclipse 15.6. The RPA is not intended to be used as a primary treatment planning system. All automatically generated contours and plans must be imported into the user's own treatment planning system for review, edit, and final dose calculation.
    Device Description
    The Radiation Planning Assistant (RPA) is a web-based contouring and radiotherapy treatment planning software tool that incorporates the basic radiation planning functions from automated contouring, automated planning with dose optimization, and quality control checks. The system is intended for use for patients with cancer of the head and neck, cervix, breast, and metastases to the brain. The RPA system is integrated with the Eclipse Treatment Planning System v15.6 software cleared under K181145. The RPA radiation treatment planning software tool was trained against hundreds / thousands of CT Scans of normal and diseased tissues from patients receiving radiation for head and neck, cervical, breast, and whole brain at MD Anderson Cancer Center.
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