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510(k) Data Aggregation

    K Number
    K180671
    Device Name
    MINE
    Manufacturer
    Date Cleared
    2019-06-05

    (448 days)

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

    RHT Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MINE is intended to be used by trained dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.
    Device Description
    MINE, a portable dental X-ray system, operates on 11.1V DC supplied by a rechargeable LiPolymer battery pack, The X-ray tube head, controls and power source are assembled into a single hand-held enclosure. The package includes a battery charger. The portable X-ray system. MINE, 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 operating principle of MINE 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 tube head, electrical protective devices, and other elements. The MINE produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.
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