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510(k) Data Aggregation

    K Number
    K131973
    Device Name
    UNEXEF-38G ULTRASOUND SYSTEM
    Date Cleared
    2014-11-18

    (508 days)

    Product Code
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOYOTA TSUSHO CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The system is intended for use by a qualified physician for diagnostic ultrasound imaging of the human body in Peripheral Vascular vessels. The UNEXEF38G ultrasound instrument is intended to perform the following diagnostic ultrasound investigations: Imaging (A/B-Mode), Color Flow Doppler (CFD), and provides calculations of Flow mediated dilation measurements during reactive hyperemia.
    Device Description
    The UNEXEF-38G Ultrasound System is a portable, software controlled ultrasound system used to acquire and display high resolution, real-time ultrasound data in a variety of modes and clinical settings. This system is s Track 3 device that employs an ultrasound probe consisting of ultrasonic transducers arranged in a comb, whereby ultrasound can be generated by supplying electric pulse signals to a group of transducers consisting of multiple adjacent transducers in the single probe.
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