# K130695: Z5 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jun 19, 2013 after 97 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). 173 ancestors in all.
74 later devices descend from it; 2 cite it directly.
0 of 248 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 2.
- K102991: M5 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2010) Summary page 2.
- K113153: DP-20 and DP-30  Digital Ultrasonic Diagnostic Imaging System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2011) Summary page 2.

## Most influential descendants
- K132779: DC-N2/DC-N2S Diagnostic Ultrasound System (2013), 72 descendants of its own
- K150204: DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems (2015), 71 descendants of its own
- K152763: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (2015), 65 descendants of its own
- K162267: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (2016), 53 descendants of its own
- K152543: M9/M9CV/M9T Diagnostic Ultrasound System (2015), 35 descendants of its own

## Indications for use
The Z5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric 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/K130695
Methodology: https://510kreport.com/methodology