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510(k) Data Aggregation

    K Number
    K022863
    Device Name
    HTS COIL
    Manufacturer
    JOCKEY CLUB MRI ENGINEERING CENTER
    Date Cleared
    2003-02-04

    (160 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K112293
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MRI surface coil for peripheral anatomical imaging Anatomical region: Temporo-mandibular joint (TMJ), wrist and other anatomies that are no deeper than 1.5 inches fro the skin.

    Device Description

    High Temperature Superconducting (HTS) coil

    AI/ML Overview

    This 510(k) letter is for a device called "HTS Coil" (High Temperature Superconducting coil). However, the letter only states that the FDA reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.

    It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. This type of information would typically be found in the 510(k) submission itself, which is not provided in this document.

    Therefore, I cannot provide the requested information. The provided document is a regulatory approval letter, not a technical report detailing the device's performance studies.

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