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    K Number
    K062523
    Device Name
    TRU-MR LARYNGOSCOPE SET
    Manufacturer
    TRUPHATEK INTERNATIONAL, LTD.
    Date Cleared
    2006-11-17

    (81 days)

    Product Code
    CCW
    Regulation Number
    868.5540
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K041852
    Why did this record match?
    Device Name :

    TRU-MR LARYNGOSCOPE SET

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Tru-MR TM laryngoscope set is used to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

    Device Description

    The Truphatek Tru-MRTM MR conditional laryngoscope handle, battery, and blades are standard blades and handles that have been specially treated to be useable in a magnetic resonance (MR) environment. Testing has been performed according to ASTM F2052-02 in a 3.0 Tesla environment. There are many handle and blade configurations offered.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study details for the Truphatek Tru-MR™ Laryngoscope set, based on the provided documents:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    ASTM F2052-02 (MR Safety Testing)In 3.0 Tesla
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