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510(k) Data Aggregation

    K Number
    K964025
    Device Name
    MITAYA ALUMINUM INTERSPACED X-RAY GRID
    Manufacturer
    X-RAY ACCESSORY CORP.
    Date Cleared
    1997-06-13

    (249 days)

    Product Code
    IXJ
    Regulation Number
    892.1910
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Mitaya aluminum interspaced x_ray grid is a standard style of ... x-ray grid, used in conventional radiography techniques.

    Device Description

    X-Ray Grid

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to William Hague X-Ray Accessory Corporation regarding their "Mitaya Aluminum Interspaced X-Ray Grid" (K964025). This document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, or any details related to AI or MRMC studies.

    The letter is a regulatory document stating that the FDA has determined the device is substantially equivalent to a legally marketed predicate device for the stated indications for use, and therefore, it can be marketed.

    Therefore, I cannot fulfill your request for information about acceptance criteria and a study proving the device meets those criteria based on the provided text. The device described (an X-Ray Grid) is a physical accessory for conventional X-ray machinery, not an AI-powered device, and the document is a regulatory clearance letter, not a study report.

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