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510(k) Data Aggregation

    K Number
    K974240
    Device Name
    LIGHTLINE-M
    Manufacturer
    WUESTEC MEDICAL, INC.
    Date Cleared
    1997-12-22

    (40 days)

    Product Code
    IZX
    Regulation Number
    892.1610
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LIGHTLINE-M

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LightLine-M is intended for use in general purpose diagnostic radiography to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray bean.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the LightLine-M device. The document is a clearance letter from the FDA for a 510(k) submission, confirming the device's substantial equivalence to previously marketed devices. It outlines regulatory requirements but does not include details about specific performance metrics or testing results.

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