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510(k) Data Aggregation

    K Number
    K974134
    Device Name
    X-SIGHT DIGITAL IMAGING SYSTEM
    Manufacturer
    STALLION TECHNOLOGIES, INC.
    Date Cleared
    1998-01-27

    (85 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The X-Sight device is indicated for reading, storing, and converting image data from fluoroscopic x-ray systems.

    Device Description

    X-Sight Medical Digital Imaging System

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the X-Sight Digital Imaging System. It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information regarding acceptance criteria, device performance results, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or results of MRMC or standalone studies.

    The content is limited to the regulatory clearance of the device for marketing. Therefore, I cannot extract the requested information about acceptance criteria and the study proving the device meets them from the provided text.

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