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510(k) Data Aggregation

    K Number
    K051483
    Device Name
    KODAK DIRECTVIEW DR SYSTEM DETECTOR
    Manufacturer
    EASTMAN KODAK COMPANY
    Date Cleared
    2005-06-21

    (15 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K070829
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KODAK DirectView DR System Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional screen-film systems may be used.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Kodak DirectView DR System Detector. It does not contain information about acceptance criteria or specific study details to prove the device meets those criteria.

    Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided text. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than providing performance data from a specific study.

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