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510(k) Data Aggregation

    K Number
    K992689
    Device Name
    MU PLUS
    Date Cleared
    2000-02-10

    (184 days)

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

    RAD THERAPY SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MU Plus! is a quality assurance tool for monitor unit calculations performed in radiation oncology clinics. MU Plus! is designed to be used as a verification of treatment planning derived monitor unit settings or hand generated monitor unit settings. Monitor unit calculations for linear accelerators are performed by various staff of radiation oncology clinics, including medical physicists, dosimetrists, and radiation therapists. MU Plus! also contains a diode measurement verification program which predicts an expected diode reading based on a formalism similar to the monitor unit calculations.
    Device Description
    The MU Plus! monitor unit calculation verification program is designed to operate on an IBM compatible personal computer using Windows 95. Windows NT 4.0, or higher operating system. It is designed to operate independently of any radiation treatment planning system. It does not connect to or control any radiation hardware device. It is designed to verify monitor unit calculations for accelerator produced photons and electrons. It also calculates expected diode readings based on clinical data entered by the user.
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