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510(k) Data Aggregation

    K Number
    K972966
    Device Name
    AXT 150M MANUAL COLLIMATOR (AXT 150M)
    Manufacturer
    APPLIED X-RAY TECHNOLOGIES, INC.
    Date Cleared
    1997-08-21

    (10 days)

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

    AXT 150M MANUAL COLLIMATOR (AXT 150M)

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

    The AXT 150M and/or its variations is intended to be used by or under the authority of a licensed MD or RT. The AXT 150M and/or its variations is accessories to control the x-ray beam for use on a diagnostic Imaging equipment. The intended market will consist of Original Equipment Manufacturers (OEM), as designed to be adapted to various x-ray systems.

    Device Description

    AXT 150M Manual Collimator

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a medical device (AXT 150M Manual Collimator), indicating that the device is substantially equivalent to a predicate device.

    The letter and the "Indications For Use" statement do not include:

    • A table of acceptance criteria and reported device performance.
    • Details about a study or clinical trial.
    • Sample sizes, data provenance, ground truth establishment, or expert qualifications.
    • Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.
    • Training set details.

    Therefore, I cannot fulfill the request based on the provided input.

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