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510(k) Data Aggregation

    K Number
    K993819
    Device Name
    QWH-300 WRIST ARRAY COIL
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    1999-12-03

    (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 wrist and hand, that can be interpreted by a trained physician.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the OWH-300 Wrist Array Coil and its Statement of Indications for Use. It describes a medical device, specifically an MRI coil, and states its intended use. There is no information in these documents about acceptance criteria, device performance, a study proving acceptance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the input text. The documents indicate the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, not a performance study against specific acceptance criteria.

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