# K182603: Z6 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Nov 14, 2018 after 54 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: 19 generations back to K935595 (1995). 124 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122010: Z6 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2012) Summary page 5.

## Most influential descendants
- K200411: Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System (2020), 0 descendants of its own

## Indications for use
The Z6 Diagnostic Ultrasound System is applicable for adults. pregnant women, pediatric patients and neonates. It is intended for use in fetal. abdominal. pediatric. small organ(breast. thyroid. testes). neonatal and adult cephalic, trans-rectal. trans-vaginal, musculo-skeletal(conventional, superficial). adult and pediatric cardiac, peripheral vessel . intra-operative(abdominal, thoracic, and vascular) and urology exams.

Source page: https://510kreport.com/device/K182603
Methodology: https://510kreport.com/methodology