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510(k) Data Aggregation

    K Number
    K031975
    Device Name
    IMSURE
    Manufacturer
    PRODIGM, INC.
    Date Cleared
    2003-08-29

    (64 days)

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

    PRODIGM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IMSure is indicated for use as a quality assurance tool to verify IMRT treatment plans developed on any radiation therapy treatment planning system with the appropriate transfer format. IMSure will also perform primary monitor unit calculations from measured physics data for plans of known geometry.
    Device Description
    IMSure is a software program designed to provide a second, independent verification of IMRT plans created on primary radiation therapy treatment planning systems. After independently calculating the imported plan and fluence maps, IMSure compares results with the imported plan and maps, and calculates the differences. This second check provides an effective QA tool for verification of the original IMRT treatment plan. IMSure also may be used to compute primary monitor unit calculations for single and multiple beams with open, blocked, and wedged fields.
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