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510(k) Data Aggregation

    K Number
    K121854
    Device Name
    SYSTEM, X-RAY, STATIONARY
    Manufacturer
    BEIJING SINOPHARM HUNDRIC MEDILINE INFO. TECH. CO.
    Date Cleared
    2012-08-22

    (58 days)

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

    BEIJING SINOPHARM HUNDRIC MEDILINE INFO. TECH. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Digital X-ray Radiography System is indicated for use in generating radiographic image of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
    Device Description
    The Digital X-ray Radiography System is indicated for use in generating radiographic image of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications. The Digital X-ray Radiography System is designed to perform rudiographic X-ray cvario 1. consists of a control cabinet, a high voltage (HV) generator, an X-ray source assembly including an X-ray tube and an collimator, an Overhead Tube Suspension, a amorphous silicon (a-Si) detector, an elevating radiographic Table, a radiographic wall stand unit and a workstation.
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