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510(k) Data Aggregation

    K Number
    K032429
    Device Name
    QSC-127 SHOULDER ARRAY COIL SET
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    2003-08-21

    (15 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 shoulder that can be interpreted by a trained physician.

    Device Description

    Model QSC-127 Shoulder Array Coil

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA for a medical device called the "Model QSC-127 Shoulder Array Coil." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and can proceed to market subject to general controls. It also includes the stated indications for use of the device.

    Therefore, I cannot provide the requested information about acceptance criteria and a study from this document.

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