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510(k) Data Aggregation

    K Number
    K993719
    Device Name
    KAC-300 KNEE ARRAY COIL
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    1999-11-26

    (23 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 knee , foot, and ankle that can be interpreted by a trained physician.

    Device Description

    Model KAC-300 Knee Array Coil

    AI/ML Overview

    The provided documents are a 510(k) clearance letter from the FDA for a medical device (Model KAC-300 Knee Array Coil) and its associated Indications for Use statement. These documents do not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications related to the device's diagnostic capabilities.

    The 510(k) clearance letter primarily states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. The Indications for Use statement specifies that the coil is "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the knee, foot, and ankle that can be interpreted by a trained physician."

    Therefore, I cannot fulfill your request for information about acceptance criteria and the study proving the device meets them based on the provided input. This type of information would typically be found in a separate clinical study report or performance evaluation report, which is not part of this 510(k) submission summary.

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