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510(k) Data Aggregation

    K Number
    K060292
    Device Name
    KODAK MODELS 2100 AND 2200
    Manufacturer
    KODAK-TROPHY
    Date Cleared
    2006-03-03

    (25 days)

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

    Kodak 2100 and Kodak 2200, intra-oral X-ray generators are intended for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for the Kodak 2100 and Kodak 2200 intra-oral X-ray generators. It confirms that the devices are substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.

    To answer your request, I would need a document that describes the specific performance metrics, the study design, and the results of a validation study for the device.

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