Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K192388
    Device Name
    SonoVision Ultrasound Imaging System
    Date Cleared
    2020-03-12

    (191 days)

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

    Tissue Differentiation Intelligence, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SonoVision™ Ultrasound Imaging System is a general purpose ultrasound system intended for use by a qualified physician for the visualization and evaluation of nerves, vascular and other anatomical structures. The system provides imaging assistance in spinal procedure applications.
    Device Description
    The SonoVision™ Ultrasound Imaging System with Beluga1™ transducer probe is a general purpose, Track 1, ultrasound system intended for use by a qualified physician for the visualization and evaluation of nerves, vascular and other anatomical structures. The Beluga1™ is an ultrasound imaging probe that has been ergonomically designed for use in intraoperative procedures. The system is comprised of the SonoVision™ console & monitor, 10 MHz transducer imaging probe (Beluga1™), and control software. The system includes image processing software that can be used to define anatomical features in an ultrasound B-mode image. The Beluga1™ Imaging Probe has been developed for specific application in spine procedures.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1