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510(k) Data Aggregation

    K Number
    K030699
    Device Name
    VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC
    Manufacturer
    J. MORITA MFG. CORP.
    Date Cleared
    2003-05-29

    (84 days)

    Product Code
    EAG
    Regulation Number
    872.1830
    Why did this record match?
    Product Code :

    EAG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Veraviewepocs Panoramic/Cephalometric X-ray Unit With Digital Image Function is an extraoral source X-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, and oral structure by exposing an X-ray image receptor to ionizing radiation, with an optional cephalometric capability, and a digital imaging capability for taking both panoramic and cephalometric images.
    Device Description
    The Veraviewepocs Panoramic/Cephalometric X-ray Unit With Digital Image Function is an extraoral source X-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, and oral structure by exposing an X-ray image receptor to ionizing radiation, with an optional cephalometric capability, and a digital imaging capability for taking both panoramic and cephalometric images.
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    K Number
    K021372
    Device Name
    VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY
    Manufacturer
    J. MORITA USA, INC.
    Date Cleared
    2002-06-07

    (38 days)

    Product Code
    EAG
    Regulation Number
    872.1830
    Why did this record match?
    Product Code :

    EAG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Veraviewepocs Panoramic X-ray Unit with Cephalometric Capability that is the subject of this 510(k) is an extraoral source X-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, oral structure, TM-joints and skull by exposing an X-ray image receptor to ionizing radiation.
    Device Description
    The Veraviewepocs Panoramic X-ray Unit is an FDA-cleared extraoral source X-ray unit that it used for dental radiographic examination and diagnosis of teeth, jaw, and oral structure by exposing an X-ray image receptor to ionizing radiation (K#013955). The modified Veraviewepocs covered by this submission simply adds a cephalometric capability to the existing device. In addition to manual settings, the modified Veraviewepocs also has an "auto exposure" feature in the cephalometric mode. Exposure time is automatically adjusted depending on the patient's size, and the device is set at 80 kV and 10mA. A sensor behind the cephalometric cassette measures the amount of x- radiation, and the exposure is terminated once the accumulated x-radiation reaches a certain level.
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