LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K092591
    Device Name
    ORTHOPANTOMOGRAPH OP30
    Manufacturer
    INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
    Date Cleared
    2009-11-20

    (88 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K063459
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Orthopantomograph® OP30 dental panoramic x-ray equipment is indented for dental radiographic examinations by producing digital radiographs of teeth. TM-joints and other oral structures by dentists and other legally qualified professionals.

    Device Description

    Orthopantomograph® OP30 is an extraoral source dental x-ray equipment, which produces dental panoramic and TMJ images on its digital x-rav image receptor. The technique factor settings are: 66, 70, 73 or 77 kV, 10 mA and max 10 sec.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) summary for the Orthopantomograph® OP30, focusing on its intended use, technological characteristics, and substantial equivalence to a predicate device. It confirms FDA clearance but does not include details on specific performance metrics, studies, sample sizes, or ground truth establishment.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1