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    K Number
    K033567
    Device Name
    MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    2003-11-25

    (15 days)

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

    MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY 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 knee that can be interpreted by a trained physician.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification letter from the FDA regarding MRI coils, not a study report or clinical trial. Therefore, the provided text does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

    The document is an FDA clearance letter, indicating that the device (HRK-63-8 PMS and HRK-127-8 Knee Array Coils) has been deemed substantially equivalent to a legally marketed predicate device. This process does not typically involve the detailed performance studies with acceptance criteria, ground truth, and expert adjudication that would be present in a clinical trial report.

    Therefore, I cannot populate the table or answer the specific questions based on the provided text.

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