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510(k) Data Aggregation

    K Number
    K993477
    Device Name
    HRW WRIST ARRAY COIL
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    1999-11-01

    (18 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

    Model HRW Wrist Array Coil

    AI/ML Overview

    The provided documents (Images {0} and {1}) are a 510(k) clearance letter from the FDA and the corresponding Statement of Indications for Use for the MRI Devices Corporation's Model HRW Wrist Array Coil. These documents do not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance).

    The letter states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to a device already on the market. The FDA's 510(k) pathway often relies on demonstrating substantial equivalence rather than requiring extensive clinical trials with acceptance criteria and detailed performance metrics as might be seen for novel, high-risk devices.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details because it is not present in the provided text.

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