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510(k) Data Aggregation

    K Number
    K060550
    Date Cleared
    2006-03-31

    (29 days)

    Product Code
    Regulation Number
    892.1680
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KODAK DirectView DR 3000 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the Kodak DirectView DR 3000 System, a stationary x-ray system. However, it does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes (for training or testing), ground truth establishment, or expert qualifications necessary to answer the request.

    The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices, thereby permitting it to be marketed. It focuses on regulatory aspects like compliance with federal regulations, registration, labeling, and good manufacturing practices.

    Therefore, I cannot provide the requested table or details about the study because the information is not present in the given text.

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