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510(k) Data Aggregation

    K Number
    K973362
    Device Name
    NEEDLE GUIDE/GRID
    Manufacturer
    PROTEK MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-10-01

    (23 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NEEDLE GUIDE/GRID

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

    A needle guidance device for prostate biopsies or radiation seed placement/needles used as an accessory with an ultrasound transducer and system.

    Device Description

    Needle Guide/Grid

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Needle Guide/Grid for Ultrasound Transducer." This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

    The letter primarily concerns the substantial equivalence determination of the device to legally marketed predicate devices, allowing it to be marketed. It lists the regulatory class and Procode, and outlines general controls provisions.

    Therefore, I cannot fulfill your request for information on the acceptance criteria and the study that proves the device meets them, as this data is absent from the provided document.

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