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510(k) Data Aggregation

    K Number
    K031372
    Device Name
    PERSONAL DIGITAL WORKSTATION (PDW); FILM DIGITIZING CAMERA AND DIGITAL WORKSTATION
    Manufacturer
    MAXXVISION, LLC
    Date Cleared
    2003-07-02

    (63 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAXXVISION, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The hand-held device is intended to provide better visualization of mammographic films for review by radiologists. A portion of the film image is digitized, processed, and displayed in real-time as a magnified view on an adjacent monitor.
    Device Description
    The hand-held device is intended to provide better visualization of mammographic films for review by radiologists. A portion of the film image is digitized, processed, and displayed in real-time as a magnified view on an adjacent monitor.
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