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510(k) Data Aggregation

    K Number
    K122806
    Device Name
    IMAGE WORKS PANOURA
    Manufacturer
    MIC INTERNATIONAL
    Date Cleared
    2013-03-08

    (176 days)

    Product Code
    MUH
    Regulation Number
    872.1800
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    Applicant Name (Manufacturer) :

    MIC INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMAGEWORKS PANOURA dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The device must only be operated and used by dentists and other legally qualified professionals.
    Device Description
    The IMAGEWORKS PANOURA is dental panoramic and cephalometric device and intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The IMAGEWORKS PANOURA is equipped with an X-ray generator and a Sensor unit at Arm unit supported by Column unit and Sliding body unit. While rotating around the patient's teeth and jaw, the IMAGEWORKS PANOURA irradiates X-ray and detects X-ray absorbed data at the Sensor unit multiple times. Detected multiple data are transferred to an image processing unit and the data are superimposed with appropriate shift value according to the X-ray moving speed from the arm rotation to acquire image.
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