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510(k) Data Aggregation

    K Number
    K082875
    Device Name
    PORTABLE X-RAY SYSTEM, MODEL DXR -1
    Manufacturer
    Date Cleared
    2009-02-05

    (129 days)

    Product Code
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXARO CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Portable X-ray System (Model: DXR-1) is intended to be used by trained dentists and dental technicians as extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
    Device Description
    DXR-1, a portable dental X-ray system, operates on 25.2V DC supplied by a rechargeable Li-Polymer battery pack. The X-ray tubehead, controls and power source are assembled into a single hand-held enclosure. The package includes a battery charger. The potable X-ray system, DXR-1, being composed of X-ray generator, controller, and beam limiting device is designed to diagnose tooth and jaw through generated and controlled X-ray. The mechanical principle of DXR-1 starts from the generation of X-ray by high voltage electricity, which in turn penetrates tooth and jaw area after flowing through X-ray tube and produces X-ray images on X-ray receptors (i.e. chemical film or digital sensor) This device contains a high frequency inverter that converts direct to alternating current, X-ray tubehead, electrical protective devices, and other elements. The DXR-1 produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.
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