LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K100204
    Device Name
    SONALIS
    Manufacturer
    SMITH ASSOCIATES
    Date Cleared
    2010-02-19

    (25 days)

    Product Code
    ITXDEVIYO
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    SMITH ASSOCIATES

    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 examination using the SONALIS® Platform system: Prostate and Rectal wall studies.
    Device Description
    The SONALIS® is a real time, two-dimensional, diagnostic system that produces high quality images. The system currently supports imaging applications for trans-aectorl ultrasound imaging. The system consists of: - . system console, - . keyboard. - . ultrasound probe, - . ultrasound probe connector, - . power cord, - high resolution LCD monitor to display the image, - System Operating Manual ● - B&W graphic printer .
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1