LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K021631
    Device Name
    ISA-21 INTERVENTIONAL SPINE ARRAY COIL
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    2002-08-13

    (88 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the spine that can be interpreted by a trained physician.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter for the ISA-21 Interventional Spine Array Coil. The document mainly concerns the regulatory approval process and does not contain detailed information about acceptance criteria or a study demonstrating the device's performance against such criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information from the given text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1