# K122010: Z6 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jul 20, 2012 after 11 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: 18 generations back to K935595 (1995). 123 ancestors in all.
109 later devices descend from it; 5 cite it directly.
0 of 233 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102991: M5 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2010) Summary page 2.
- K083001: M5 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2008) Summary page 2.
- K100830: M7/M7T Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2010) Summary page 2.
- K103583: DC-7 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2010) Summary page 2.
- K090912: Digital Ultrasonic Diagnostic Imaging System, Model DP-6900, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2009) Summary page 2.

## Most influential descendants
- K123185: DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound System (2012), 97 descendants of its own
- K132341: DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound Systems (2013), 96 descendants of its own
- K141010: M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System (2014), 83 descendants of its own
- K150080: DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S (2015), 79 descendants of its own
- K123503: DC-N3/DC-NS3 Diagnostic Ultrasound System (2012), 77 descendants of its own

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

Source page: https://510kreport.com/device/K122010
Methodology: https://510kreport.com/methodology