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510(k) Data Aggregation

    K Number
    K032355
    Device Name
    ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW
    Manufacturer
    DENTSPLY GENDEX
    Date Cleared
    2003-09-25

    (57 days)

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

    DENTSPLY GENDEX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System is to be used as an extraoral source of x-rays for imaging of the dentomaxilofacial area.
    Device Description
    The DENTSPLY International, Gendex Division Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System is an extraoral source of x-rays for imaging of the dentomaxilofacial area. The DENTSPLY International, Gendex Division Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System is comprised of the following main components: - High frequency inverter which supplies a true DC output and accurate technique factors . - A microprocessor controlled user-friendly electronic control . - A motorized column to be fixed to the wall ● - Counter balanced overhead carriage with controls for patient positioning, setting and control . of technique factors and radiographic projection geometry - Cassette drive system with flat cassette for 15x30 cm film - X-ray tubehead, with DC power supply via electronic converter . - Remote control box and handswitch - . Optional cephalometric arm and head postioner - Optional utilities for transverse scanography of the jaw ("Transcan®") ● During a panoramic exposure, the x-ray tube and cassette holder moves around the patient's head. The beam from the x-ray tube is collimated by a slit diaphragm. The flat film cassette passes behind a secondary collimator which blocks the radiation scattered from the patient. Patient positioning is by means of a bite guide and a headrest. During exposure, the patient, remains still while the motorized components rotate. All movements for the panoramic radiographic projection are performed by four independent motors, which are microprocessor controlled.
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