LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K062449
    Device Name
    EMPOWERMR INJECTOR SYSTEM, MODEL 9730
    Manufacturer
    E-Z-EM, INC.
    Date Cleared
    2007-04-13

    (234 days)

    Product Code
    IZQ,JZQ
    Regulation Number
    870.1650
    Type
    Abbreviated
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EMPOWERMR INJECTOR SYSTEM, MODEL 9730

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

    EmpowerMR: Vascular administration of contrast media and flushing media in conjunction with magnetic resonance (MR) imaging.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA 510(k) clearance letter for the "E-Z-EM EmpowerMR Injector System and Fastload MR Syringe Pack." It describes the device's indications for use and states that it has been found substantially equivalent to a predicate device.

    However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt. Therefore, I cannot generate the detailed response you are looking for based solely on this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1