# K182165: Color Doppler Ultrasound System; Model: mEye1 and mEye2

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Well.D Medical Electronics Co., Ltd.
- Decided: Dec 20, 2018 after 132 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: 5 generations back to K935595 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113613: Digital Color Doppler Ultrasound Imaging System, Shantou Institute of Ultrasonic Instuments (2012) Summary page 7.

## Indications for use
Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular, trans-vaginal and trans-rectal applications in B, M, PWD and Color Doppler modes.

Source page: https://510kreport.com/device/K182165
Methodology: https://510kreport.com/methodology