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510(k) Data Aggregation

    K Number
    K151014
    Device Name
    Aura DR 43C-AG flat panel detector
    Manufacturer
    Date Cleared
    2015-07-13

    (88 days)

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

    ABYZR CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AURA DR 43C-AG detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. It is not to be used for mammography.
    Device Description
    AURA DR 43C-AG is a digital X-ray flat panel detector which has 43cm x 43cm imaging area and communicates with a wired communication feature, Giga-bit Ethernet communication method through connecting a tether cable. The device intercepts x-ray photons and the scintillator (Gadox:Tb) and emits visible spectrum photons that illuminate an array of photo (a-SI) detector that creates electrical signals. After the electrical signals are generated, it is converted to digital values, and the images will be displayed on the monitor. This device should be integrated with an operating PC and an X-Ray generator. It can digitalize x-ray images and transfer them for radiography diagnostics. Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, and sharing of image information on network.
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