SonoVision Ultrasound Imaging System
Tissue Differentiation Intelligence, LLCThe SonoVision Ultrasound Imaging System is a general-purpose ultrasound device designed to help physicians visualize nerves, vascular structures, and other anatomical features, especially during spinal procedures. It uses a specialized ultrasound probe and advanced image processing software to provide real-time imaging assistance, enhancing the accuracy and safety of medical interventions.
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.
Technology
The system includes the SonoVision console and monitor, a 10 MHz reusable transducer imaging probe (Beluga1), and proprietary control and image processing software that can segment anatomical features on B-mode ultrasound images. It supports B-mode imaging, Doppler color flow mapping, and real-time 2D bone and tissue scanning, with low RF emissions and touch screen control.
Performance
The device was evaluated for performance, acoustic output, biocompatibility, cleaning, sterilization, thermal, electrical, electromagnetic, and mechanical safety according to recognized standards (IEC 60601 series, ISO 10993-1, ISO 14937). In vivo testing demonstrated its performance in human applications. The results showed substantial equivalence to predicate devices and compliance with safety and performance requirements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/3/2019
6 months - 2
FDA Approval
3/12/2020
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