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510(k) Data Aggregation

    K Number
    K050299
    Device Name
    HRK-123 KNEE ARRAY COIL
    Manufacturer
    MRI DEVICES CORPORATION
    Date Cleared
    2005-02-24

    (17 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K082636
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To be used in conjunction with a Magnetic Resonance Scanner to produce images that can be interpreted by a trained physician.

    Device Description

    HRK-123 Knee Array Coil

    AI/ML Overview

    I am sorry, but the provided text from the FDA Pre-Market Notification (510(k)) K050299 for the HRK-123 Knee Array Coil does not contain information about acceptance criteria or a study that proves the device meets those criteria.

    This document is a letter from the FDA granting substantial equivalence to the device, allowing it to be marketed. It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It does not include details of the performance testing, clinical studies, or specific acceptance criteria that would be relevant to the questions asked.

    Therefore, I cannot provide the requested information based on the input text.

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