# K192388: SonoVision Ultrasound Imaging System

- Pathway: 510(k) (Abbreviated)
- Applicant: Tissue Differentiation Intelligence, LLC
- Decided: Mar 12, 2020 after 191 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K935595 (1995). 93 ancestors in all.
No later device cites it as a predicate yet.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132736: Accuro 3000 Ultrasound Scanner, Rivanna Medical, LLC (2014) Summary page 4.

## Indications for 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.

Source page: https://510kreport.com/device/K192388
Methodology: https://510kreport.com/methodology