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510(k) Data Aggregation

    K Number
    K102153
    Device Name
    MOBIUS ULTRASOUND IMAGING SYSTEM
    Manufacturer
    MOBISANTE, INC.
    Date Cleared
    2011-01-20

    (174 days)

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

    MOBISANTE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MobiUS Ultrasound Imaging System is indicated for ultrasound imaging, measurement and analysis of the human body for the following clinical applications: fetal/OB, abdominal, cardiac, pelvic, pediatric, musculoskeletal, and peripheral vessel imaging. Its compact size, portability and user interface enable it for use in primary care and special care areas.
    Device Description
    The MobiUS Ultrasound Imaging System is a compact, portable ultrasound imaging system consisting of a handheld ultrasound probe, cable, host computer and user interface. The ultrasound probe and cable is one of the five models of the INTERSON USB Ultrasound Imaging Probe, ranging from 3.5 MHz to 12.0 MHz. The probes consist of a single-element mechanical sector scanner that contains the ultrasound generator and receiver, analog-todigital converter, microcontroller, control logic, USB 2.0 interface and control within the hand piece. It has a push button control to activate scanning. The probe is connected via a USB cable to a host computer. The host computer comes preloaded with the MobilUS software which utilizes an icon touch-based user interface. The software enables ultrasound image capture and review, image controls for near, mid, and far gain, as well as image intensity and contrast, linear measurement, storage and transmission of images and videos. The MobiUS Ultrasound Imaging System allows the user to image in real-time and review cine or freeze-frame images on the screen in B-Mode scan format.
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