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    K Number
    K040652
    Device Name
    VUE 100 ULTRASOUND IMAGING SYSTEM
    Manufacturer
    MOBILSONIC, INC.
    Date Cleared
    2004-05-17

    (67 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOBILSONIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VUE 100 ultrasound system is used by or under the direction of a certified physician to perform general non-invasive diagnostic ultrasound imaging studies, to include: abdominal, peripheral vascular, fetal, and small organ applications. Small organs include Thyroid, Breast, and Testicles.
    Device Description
    The VUE 100 is a portable ultrasound system. It is used to acquire and display real time 2D ultrasound images. Currently the system supports two mechanical sector probes, 4S2 (3MHz) and 6S4 (5MHz).
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