LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K022588
    Device Name
    HRW-63-INT WRIST ARRAY COIL
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    2002-09-04

    (30 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HRW-63-INT WRIST ARRAY COIL

    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 wrist and hand, that can be interpreted by a trained physician.

    Device Description

    Model HRW-63-INT Wrist Array Coil

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for an MRI coil, not a study report for an AI/ML device. Therefore, it does not contain the information required to populate the requested tables and answer the questions about acceptance criteria, study design, and performance for an AI/ML device.

    The document states that the "Model HRW-63-INT Wrist Array Coil" is "to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the wrist and hand, that can be interpreted by a trained physician." This is a description of the device's intended use, not performance criteria.

    Without a detailed study report describing the evaluation of an AI/ML device, it's impossible to provide the requested information.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1