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510(k) Data Aggregation

    K Number
    K113497
    Device Name
    HYPERION
    Manufacturer
    CEFLA S.C. CEFLA DENTAL GROUP
    Date Cleared
    2012-01-17

    (53 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K133797
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA to Cefla S.C. Cefla Dental Group regarding the 510(k) premarket notification for their device, "hyperion." It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

    The document discusses:

    • The FDA's determination of substantial equivalence.
    • Regulatory classifications and requirements for the device.
    • Contact information for various FDA offices.
    • Indications for Use for the "hyperion" device (digital panoramic and cephalometric extra-oral X-ray system).

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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