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510(k) Data Aggregation

    K Number
    K062878
    Device Name
    EZPACS, VERSION 3.0
    Date Cleared
    2007-06-27

    (274 days)

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

    ADVANCED IMAGING SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    EZPACS® is intended for use by radiologists (for primary diagnosis), and other medical professionals who needs access to radiological images and reports. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
    Device Description
    EZPACS® is a PACS system that runs on off-the-shelf monitors and PCs running the Microsoft Windows® operating system. It consists of software that displays images and provides functions for image manipulation, enhancement, compression and quantification.
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