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510(k) Data Aggregation

    K Number
    K972365
    Device Name
    COMPACT OR COMP-X
    Manufacturer
    Date Cleared
    1997-12-12

    (170 days)

    Product Code
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROTEC, S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended to be moved in a hospital or clinic or other facility to provide capability of X-ray exposures in remote areas, or in instances where stationary devices are unsuitable. The device is designed to be used in conjunction with a cassette film or other image receptor, in order to provide a radiological exposure of the human body, to serve as an aide in diagnosing illnesses and fractures. The unit is not intended to treat, prevent, cure, mitigate or otherwise medicate ailments. THE UNIT IS INTENDED FOR USE ON GENERAL RADIOGRAPHIC PROCEDURES.
    Device Description
    The device appears as a mobile unit and is composed of three parts: The X-ray generator (monoblock), the X-ray controller, and the mechanics which allow the device to be moved on wheels and the X-ray generator to be positioned. The X-ray generator is constituted of an X-ray tube with rotating anode, encased in metal casing which also contains the high voltage generator. The monoblock is attached to a Beam Limiting Device (BLD). The monoblock and the X-ray emission are controlled by an X-ray controller, an electronic device connected to the monoblock through low tension cables. The device is designed to be transported on wheels and has an arm structure that supports the X-ray source, allowing for vertical and pivotal movements. The X-ray source is attached to the arm by means of gimbals, allowing z-axis and x-axis rotation. The BLD is also capable of swiveling on its vertical axis. The device performs X-ray exposures using a two-step push button, with the operator selecting kVp and mAs settings. The exposure process involves prepping the exposure (warming the filament and spinning the anode) and then initiating the emission of radiation. The X-ray controller monitors the process and can abort the exposure if problems are encountered. Exposures can also be manually aborted by the operator.
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