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510(k) Data Aggregation

    K Number
    K171012
    Device Name
    Veraview X800
    Manufacturer
    Date Cleared
    2017-12-19

    (259 days)

    Product Code
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    J.Morita USA, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Veraview X800 is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography. The Veraview X800 is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the dento-maxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation. The device uses a cone shaped X-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations. The device is to be operated and used by dentists and other legally qualified professionals for pediatric and adult patients.
    Device Description
    The Veraview X800 consists of the following components: x-ray arm with extraoral x-ray source assembly faced with x-ray detector, cephalometric support, high-voltage generator, control assembly, patient positioning device, and software containing communication and image construction. The Veraview X800 has three main radiographic modes as follows: - Panoramic tomography including linear tomography and scanogram - - Cephalometric radiography - - -Cone beam computed tomography
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