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510(k) Data Aggregation

    K Number
    K972968
    Device Name
    ROTOGRAPH PLUS
    Manufacturer
    CHICAGO X-RAY SYSTEMS, INC.
    Date Cleared
    1997-10-08

    (58 days)

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

    CHICAGO X-RAY SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Rotograph Plus as manufactured by Villa Sistemi Medicali S.p.A of Milan, Italy is intended to be used as an extra oral radiological device for the examination of the human dentition and related anatomy as well as craniostatic examinations. They are to be used for Panoramic and Cephalometric Radiology as it is applied to dental diagnosis in dentistry.
    Device Description
    This product is manufactured by the Villa Sistemi Medicali company of Milan, Italy and is classified as a class II device. It is intended to be used as a dental extra oral x-ray device for the panoramic and cephalometric examination of the human anatomy as it applies to dentistry.
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