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510(k) Data Aggregation

    K Number
    K040288
    Device Name
    QSC-127-INT SHOULDER ARRAY COIL SET
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    2004-03-05

    (28 days)

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

    QSC-127-INT SHOULDER ARRAY COIL SET

    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 when interpreted by a trained physician.

    Device Description

    Model QSC-127-INT Shoulder Array Coil Set

    AI/ML Overview

    I'm sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (Model QSC-127-INT Shoulder Array Coil Set). It confirms the device's substantial equivalence to predicate devices and outlines regulatory compliance.

    However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies. It is a regulatory approval letter, not a technical report or study summary.

    Therefore, I cannot extract the requested information from this text.

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