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510(k) Data Aggregation

    K Number
    K022389
    Device Name
    READI-LOAD SYSTEM, MODEL PSS 1820RL
    Manufacturer
    WORLDWIDE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2003-05-06

    (287 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    READI-LOAD SYSTEM, MODEL PSS 1820RL

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

    The Worldwide Medical Technologies Readi-Load intended use is to provide a pre-sterilized needle carrier for radionuclide seeds for the introduction of radionuclide seeds into the body for Brachytherapy procedures.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the "Readi-Load System." It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information about acceptance criteria or a study demonstrating the device's performance against such criteria. The letter is an administrative notification of FDA clearance, not a scientific study report.

    Therefore, I cannot fulfill your request as the necessary information is absent from the provided input.

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