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510(k) Data Aggregation

    K Number
    K133496
    Device Name
    X TWIN SYSTEM
    Manufacturer
    Date Cleared
    2014-12-03

    (384 days)

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

    ROESYS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The X Twin is intended to be used as a digital multifunctional x-ray system, suitable for all radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography. X Twin shall only be operated by qualified, trained professionals. The patient can be in sitting, lying or standing position. The device is a permanently installed device and is intended to be operated in medical rooms with appropriate radiation protection only. It is not intended to be used with flammable anesthetic agents or in potentially explosive atmospheres.
    Device Description
    The X Twin is a digital multifunctional x-ray system, in which an X Twin stand holds the xray image receptor, the collimator and the x-ray tube including the x-ray tube housing assembly. The generator, x-ray tube, beam limiting device, image receptor, including the workstation for image processing plus imaging software and the optional mobile x-ray table are known components. The geometry of the X Twin contains two guide frames, two support arms, an x-ray tube column and an image receptor column. The movements of the columns and the arms as well as the SID adjustment are motorized. The x-ray tube support arm as well as the image receptor support arm is provided with an integrated control unit, located at the front of the support arms. These units allow an adjustment of angle, height and distance of the image receptor and x-ray in relation to the patient. Simultaneously an integrated electronic control system provides automatic focusing of the image receptor and x-ray tube. Additionally an integrated touch display for indication of current values and additional control options is implemented in the tube support arm. The device receives its power from the x-ray generator.
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