# K200251: Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Apr 2, 2020 after 59 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). 174 ancestors in all.
No later device cites it as a predicate yet.
0 of 175 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130695: Z5 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2013) Summary page 14.

## Indications for use
Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Fetal, Abdominal, Pediatric, Musculo-skeletal（conventional, superficial）, Peripheral Vascular, Trans-rectal, Trans-vaginal, Small organ（breast, thyroid and testes）, Cephalic（neonatal and adult）, Cardiac（adult and pediatric）and Urology exams.

Source page: https://510kreport.com/device/K200251
Methodology: https://510kreport.com/methodology