Search Results
Found 1 results
510(k) Data Aggregation
K Number
K192388Device Name
SonoVision Ultrasound Imaging System
Manufacturer
Date Cleared
2020-03-12
(191 days)
Regulation Number
892.1550Why 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