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510(k) Data Aggregation

    K Number
    K990475
    Device Name
    TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5
    Manufacturer
    Date Cleared
    1999-11-18

    (275 days)

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

    **KPS **& ASSOC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TraPIS (Transperineal Prostate Implant Simulator) is a software (computer program) designed for planning and post-implant verification of brachytherapy for carcinoma of the prostate gland. The isotope library includes Palladium (103Pd), Iodine (125I) and Iridium (192Ir) seeds. TraPIS is intended for clinical as well as research and academic use.
    Device Description
    In summary, the software is designed to provide a threedimensional radiation dose distribution in the form of isolines (contours of equal dose) or point-dose-values for a specified seed pattern. An ultrasound-guided prostate boundary dictates the seed locations. A treatment plan consisting of seed strength and distribution can be developed such that the specified radiation dose distribution is achieved within the prostate boundary. Post-implant verification involves relocating the seeds to their actual locations revealed through CT scans and/or radiographs and recalculating the dose distribution.
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