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510(k) Data Aggregation

    K Number
    K994117
    Device Name
    MR ENHANCER
    Manufacturer
    I.Z.I. CORP.
    Date Cleared
    2000-02-04

    (60 days)

    Product Code
    LNH
    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

    MR Enhancer is designed for use as a MRI accessory to improve image homogeneity by reducing skin-air interfaces, thereby images from such pulsing parameters as chemical shift fat saturation and gradient echo. MR Enhancer also serves as a stabilizing device to reduce vascular and tissue pulsation artifacts.

    Device Description

    MR Enhancer

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA to I.Z.I. Corporation for their device "MR Enhancer". This letter confirms substantial equivalence of the device to legally marketed predicate devices.

    However, this document does not contain any information regarding acceptance criteria, reported device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or ground truth establishment.

    The document primarily focuses on FDA's regulatory decision regarding substantial equivalence. It describes the device's intended use as an MRI accessory to improve image homogeneity and reduce artifacts by reducing skin-air interfaces and stabilizing the patient.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the information provided.

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