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510(k) Data Aggregation

    K Number
    K973958
    Device Name
    GENERAL PURPOSE ATL NEEDLE GUIDE KIT
    Manufacturer
    PROTEK MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-01-22

    (98 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The General Purpose ATL Needle Guide Kit consists of accessories for the Model ATL C3 Scanhead which are used for guiding a needle or catheter during a diagnostic ultrasound procedure in order to perform a biopsy or precise needle placement. The subject device is to be used only for those indications which have been FDA-cleared for the Model ATL C3 Scanhead (consult transducer manual).

    Device Description

    General Purpose ATL Needle Guide Kit for use with ATL Ultrasound Transducers

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a General Purpose Needle Guide Kit. It is a regulatory document and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot extract the requested information from this document.

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