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510(k) Data Aggregation

    K Number
    K152813
    Device Name
    FS-500DDR Medical Radiographic X-Ray System
    Date Cleared
    2016-12-02

    (431 days)

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

    ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    FS-500DDR Medical Radiographic X-Ray System is designed to be used by a qualified/trained doctor or technician on adult and pediatric patients for taking diagnostic images of the skull, spinal column, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
    Device Description
    The FS-500DDR is a Medical Radiographic X-Ray System with digital radiography (DR) technology. It is consisting of a high voltage generator, control console, X-Ray tube assembly, collimator, UC bracket or Rail suspension assembly, solid-state X-Ray flat panel detector, work station and radiographic table. This product is applicable to clinical diagnostic radiography in all hospitals whether large or small. It is applicable to the radiography of various parts of human body. It can also be used in scientific research and education of medical scientific research institutes and medical colleges.
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