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510(k) Data Aggregation

    K Number
    K032090
    Device Name
    NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    2003-08-21

    (45 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 diagnostic images of the head and neck, that can be interpreted by a trained physician.

    Device Description

    Model NVA-127-8 Neurovascular Array Coil

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for a medical device (MRI Neurovascular Array Coil). It does not contain any information about acceptance criteria, study design, or device performance metrics.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based only on the input provided. The letter simply states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing.

    To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or the 510(k) submission itself, which would detail the performance data and the methods used to collect it.

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