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510(k) Data Aggregation

    K Number
    K052661
    Device Name
    QUIX DIGITAL RADIOGRAPHIC UPGRADE
    Manufacturer
    EDGE MEDICAL DEVICES LTD.
    Date Cleared
    2006-06-07

    (253 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    EDGE MEDICAL DEVICES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quix Digital Radiography Upgrade is based on a solid state imaging device and is intended for use in general radiographic examinations and applications wherever conventional film-screen systems may be used, excluding mammography, fluoroscopy, and angiography.
    Device Description
    The Quix Digital Radiography Upgrade enables a conventional film-screen X-ray system to perform digital radiography exams by replacing the film-screen and the film-screen bucky with a digital bucky and operator console. The digital bucky incorporates a selenium-based flat panel detector with 16" x 17" imaging area. Images are displayed in approximately 10 seconds after exposure over a wide range of dose settings. The operator console provides local image storage and communicates with other network devices using DICOM 3.0 protocols.
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