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510(k) Data Aggregation

    K Number
    K082972
    Device Name
    KODAK 9500
    Manufacturer
    TROPHY
    Date Cleared
    2008-12-05

    (60 days)

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

    Kodak 9500 Extra-oral x-ray imaging system is intended to produce three dimensional xray image of the dento-maxillo-facial area.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to complete the request. The document is a 510(k) clearance letter from the FDA, which confirms substantial equivalence to a predicate device. It does not include information about specific acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for the Kodak 9500 device.

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