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510(k) Data Aggregation

    K Number
    K133797
    Device Name
    QMASTER-H/REVO
    Date Cleared
    2014-09-04

    (265 days)

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

    TELESYSTEMS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    QRmaster-H/Revo is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery. The device accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume, and displaying both 2D images and 3D renderings. This technique is known as cone beam computed tomography, or CBCT.
    Device Description
    QRmaster-H/Revo is an extraoral 2D (panoramic) and 3D (CBCT) x-ray imaging system for use by dental professionals. The device is designed to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the body by lput the same axial plane taken at different angles. To accomplish this it uses a cone-shaped xray beam projected on a flat panel detector to capture a rapid series of 2D images using the standard narrow beam technique. Such images from a single 360° scan are reconstructed with special software to be viewed on 3D viewing stations (PCs) that are not part of the system. The system makes use of a single flat panel detector for both panoramic and cone beam images. Three field of views (FOVs) provide targeted regions of interest that can be positioned by panoramic scout, two-dimensional scout, or four positioning laser beams. QRmaster-H/Revo includes firmware to operate the device through a control panel attached to the main device. The device also includes image acquisition software that stores 3D images in standard DICOM format for export to third party viewing or image management software not part of the system. Users are expected to have or acquire such image management software for communication both with the device's image acquisition software and with third party 3D-viewing software. These latter applications are readily available in the domestic marketplace.
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