Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K113497
    Device Name
    HYPERION
    Date Cleared
    2012-01-17

    (53 days)

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

    CEFLA S.C. CEFLA DENTAL GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The hyperion is a digital panoramic and cephalometric extra-oral X-ray system, indicated for use in: - producing panoramic X-ray images of the maxillofacial area, for (i) diagnostic examination of dentition (teeth), jaws and oral structures; and - · producing radiographs of the jaws and parts of the skull, for the (ii) purpose of cephalometric examination if equipped with CEPH arm.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1