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510(k) Data Aggregation

    K Number
    K033960
    Device Name
    OLINDA/EXM
    Manufacturer
    VANDERBILT UNIVERSITY
    Date Cleared
    2004-06-15

    (176 days)

    Product Code
    IYX
    Regulation Number
    892.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    VANDERBILT UNIVERSITY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The purpose of Olinda EXM is to estimate the radiation dose received by internal organs as a result of administering a radiopharmaceutical.
    Device Description
    The personal computer code OLINDA, which is an acronym standing for Organ Level INternal Dose Assessment/EXponential Modeling, calculates radiation doses to different organs of the body from radiopharmaceuticals which are administered systemically (mostly intravenously, but sometimes by oral or inhalation intake routes).
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