# K201971: SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: CHISON Medical Technologies Co., Ltd.
- Decided: Feb 25, 2021 after 225 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 Fetal, Abdominal, OB/GYN, Urology, Cardiac. 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/K201971
Methodology: https://510kreport.com/methodology