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510(k) Data Aggregation

    K Number
    K023229
    Device Name
    S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE
    Manufacturer
    AMERICAN MAMMOGRAPHICS, INC.
    Date Cleared
    2002-12-13

    (77 days)

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

    AMERICAN MAMMOGRAPHICS, 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
    AMERICAN MAMMOGRAPHICS, INC. intends to construct a full breast compression device from gamma stabilized LEXAN® or polycarbonate equivalent plastic currently used in the manufacture of numerous radiological and medical devices. The compression device will readily adapt to existing paddle arms from current OEMs and will also be available as a complete device with compression plate, yoke and mounting arm/shaft; The proposed device is a special octimized full breast compression tray called S.O.F.T. Paddle™ and will allow the targeted area to be imaged accurately, will allow more breast tissue to be imaged, and permit thinning of tissue where it is needed most. The S.O.F.T. Paddle™ proposes to offer full breast coverage with the compression plate set at an angle, downward from the chest wall toward the nipple, for better compression of anterior structures; thus it is a Special Optimized Full Compression Trav . When used for screening views, additional breast tissue can be compressed from the mid-breast to the nipple with improvement to the imaged area.
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