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510(k) Data Aggregation

    K Number
    K961525
    Device Name
    ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    1996-09-05

    (136 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K961525
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Model OBC-63 PA Open Breast Coil

    AI/ML Overview

    This document, K961525, is a 510(k) substantial equivalence letter for the Model OBC-63 PA Open Breast Coil, a magnetic resonance diagnostic device. This document does NOT contain information regarding acceptance criteria or a study proving device performance.

    The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a predicate device, or if it has different technological characteristics, the information submitted demonstrates that the device is as safe and effective as a legally marketed device.

    To address your request, specifically for details about acceptance criteria and a study that proves the device meets them, that information would typically be found in the original 510(k) submission, not in the FDA's decision letter. The FDA letter only indicates that the submitted information (which would have included such studies) was sufficient to demonstrate substantial equivalence.

    Therefore, I cannot provide the requested information from the provided text.

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