# K201968: SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: CHISON Medical Technologies Co., Ltd.
- Decided: Feb 26, 2021 after 226 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: 20 generations back to K935595 (1995). 175 ancestors in all.
No later device cites it as a predicate yet.
6 of 176 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192226: Lumify Diagnostic Ultrasound System, Philips Health Care (2019) Summary page 4.

## Indications for use
The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, CFM, Combined (B+CFM), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for Abdominal, Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric. The Digital Color Doppler Palm Ultrasound System is intended for use in environments where healthcare is provided by healthcare professionals.

Source page: https://510kreport.com/device/K201968
Methodology: https://510kreport.com/methodology