LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K013508
    Device Name
    HRH-127-ALLEGRA HEAD ARRAY COIL
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    2001-11-20

    (29 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Special
    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 16 be about images of the head, that can be interpreted by a trained physician.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but this document is a 510(k) premarket notification letter from the FDA to MRI Devices Corporation regarding their HRH-127 Allegra Head Array Coil. It confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

    This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1