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510(k) Data Aggregation

    K Number
    K024342
    Device Name
    RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000
    Manufacturer
    DAITO CO., LTD.
    Date Cleared
    2003-04-23

    (117 days)

    Product Code
    IXW
    Regulation Number
    892.1900
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To be used for processing of radiographed films.

    Developing exposed x-ray film.

    Device Description

    Designed solely for processing of radiographed films, by roller transport system and by use of developer/fixer solutions(that are to be locally obtained).

    AI/ML Overview

    The provided document is a 510(k) summary for a Radiographic Film Processor and does not contain information about acceptance criteria or a study proving that a device meets those criteria, as it is a traditional medical device (film processor) and not an AI/ML-based device.

    Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details cannot be extracted from this document. The document focuses on the physical characteristics, intended use, and non-clinical tests for electrical safety and performance of the film processor.

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