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510(k) Data Aggregation

    K Number
    K022487
    Device Name
    MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    2002-08-23

    (25 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 elbow that can be interpreted by a trained physician.

    Device Description

    Model EXS-63-INT Small Extremity Array Coil

    AI/ML Overview

    I'm sorry, but this document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria. The provided text is a 510(k) clearance letter from the FDA for a specific MRI coil (Model EXS-63-INT Small Extremity Array Coil), indicating it is substantially equivalent to a predicate device.

    The letter discusses regulatory classifications, general controls, and compliance requirements but does not include:

    • A table of acceptance criteria or reported device performance.
    • Details about a study (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set information).

    The core of this document is the FDA's determination of substantial equivalence, which is a regulatory pathway and not a detailed performance study as you described.

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