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510(k) Data Aggregation

    K Number
    K965072
    Device Name
    PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT
    Manufacturer
    Date Cleared
    1997-01-27

    (39 days)

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

    KAYCOR INTL., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Panoura ULTRA Pan and Panoura ULTRA Pan/Ceph will be marketed for diagnostic radiographic use in dental, oral surgery, and orthodontic practices, and in other medical facilities where these types of dental radiographs are routinely taken. These uses are typical of the predicate devices in the Panoura-10 series.
    Device Description
    The Panoura ULTRA Pan and Panoura ULTRA Pan/Ceph Panoramic/Cephalometric Xray Units are microprocessor controlled X-ray generator and film handling units designed mainly for dental applications. The patient stands facing the unit and is positioned by devices built into the unit. The exposure is begun under control of the operator, and the X-ray source and film rotate so as to produce a panoramic film for diagnostic use.
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