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510(k) Data Aggregation

    K Number
    K043189
    Device Name
    SONALIS, MODEL 2000
    Date Cleared
    2005-02-09

    (84 days)

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

    3G ULTRASOUND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sonalis system and transducers are intended for diagnostic ultrasound imaging of the human body. The clinical application is trans-rectal imaging. Typical examinations using the Sonalis Platform system: Prostate and rectal wall studies.
    Device Description
    The Sonalis System is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The device consists of two parts: the system console and the transducer. The console contains the user interface, a display, system electronics and optional peripherals (printers). The removable transducers are connected to the system using standard technology. The Sonalis system uses standard transducer technology and supports linear and curved linear arrays. The Sonalis system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis.
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