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510(k) Data Aggregation

    K Number
    K971431
    Device Name
    UMI X-RAY FILM CASSETTE
    Manufacturer
    UMI INTL.
    Date Cleared
    1997-05-20

    (33 days)

    Product Code
    IXA
    Regulation Number
    892.1850
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    X-Ray Film's Change for X-Ray Machine

    Device Description

    X-Ray Film Cassette/Radiographic

    AI/ML Overview

    The provided documents are a 510(k) clearance letter from the FDA and an "Indications for Use Statement" for an "X-Ray Film Cassette/Radiographic" device. These documents do not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria for software or AI-driven medical devices.

    The FDA letter (K971431) dates back to May 20, 1997, and is for a physical X-ray film cassette. At that time, AI-powered medical devices as we know them today did not exist, and the regulatory pathway for such devices, including requirements for performance studies, was not established in the same way.

    Therefore, I cannot provide the requested information based on the provided text. The document is about a traditional hardware component for X-ray imaging, not a digital or AI-driven diagnostic tool.

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