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510(k) Data Aggregation

    K Number
    K033202
    Device Name
    ADVANTAGE PADDLE
    Manufacturer
    LIVINGSTON PRODUCTS, INC.
    Date Cleared
    2003-12-03

    (62 days)

    Product Code
    IZH
    Regulation Number
    892.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIVINGSTON PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in Screening Mammographic Imaging as a Specialty Paddle for Full Breast Compression as an alternative to conventional breast compression paddles.
    Device Description
    The Advantage paddle is a breast compression paddle comprising of a rectangular tray-like structure of an FDA approved biocompatible material (Eastman Kodak PETG Copolyester #6763). The paddle has a flat section and a tilted section made possible by two-section construction. The first section of the paddle is foamed rigidly and is positioned near the patient's chest and extends about one inch away from the chest. In operation, this provides a vertically oriented force to the breast that tends to keep the breast tissue from being forced into the chest wall and provides a clearer film of the breast tissue adjacent the chest. The scond section is formed and structured to flex for the purpose of tilting the paddle downward to compress the nipple end of the breast in a steady position as the X-ray is taken. The "Advantage" paddle is mcant for use with an 18 x 24cm bucky. That is a standard size used in the industry
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