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510(k) Data Aggregation

    K Number
    K050514
    Device Name
    MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS
    Manufacturer
    MRI DEVICES CORPORATION
    Date Cleared
    2005-03-25

    (24 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS

    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 foot and ankle that can be interpreted by a trained physician.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device (MRI coils for foot and ankle imaging), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and training data for AI/ML performance is not applicable to this document.

    The document states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a device already on the market, but it doesn't involve the types of performance and validation studies typically associated with AI/ML systems.

    Therefore, I cannot provide the requested table and study details as they are not present in the provided text.

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