LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K981470

    Validate with FDA (Live)

    Device Name
    WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE
    Manufacturer
    WORLDWIDE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    1998-06-19

    (57 days)

    Product Code
    IZH
    Regulation Number
    892.1710
    Type
    Traditional
    Panel
    Radiology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intendended use of the Worldwide Medical Technologies Needle Guide for Lorad Stereotactic Device is to hold the needle in the stereotactic device for precise location of the needle tip in the needle biopsy of the breast. This device is intended to be used with the Lorad Stereotactic Device only.

    Device Description

    Worldwide Medical Technologies Needle Guide for Lorad Stereotactic Device

    AI/ML Overview

    The provided text ({0} and {1}) is a 510(k) clearance letter from the FDA for the "Worldwide Medical Technologies Needle Guide for Lorad Stereotactic Device." This document approves the device for marketing based on its substantial equivalence to a predicate device.

    However, the provided text does not contain any information about acceptance criteria, a study proving the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    The letter is a regulatory approval, not a technical report or scientific publication detailing a study about the device's performance. It confirms that the FDA reviewed the 510(k) submission, which would have included such information, but the specific details of that submission are not present in the provided text.

    Therefore, I cannot fulfill your request as the necessary information is not available in the input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1