# K152543: M9/M9CV/M9T Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Oct 29, 2015 after 55 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: 23 generations back to K935595 (1995). 218 ancestors in all.
35 later devices descend from it; 5 cite it directly.
0 of 254 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141010: M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2014) Summary page 20.
- K150080: DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2015) Summary page 20.
- K121062: Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound System, Ge Medical System Israel, Ltd. (2012) Summary page 20.
- K143472: TE7 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2015) Summary page 20.
- K150204: DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2015) Summary page 20.
- K132913: Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10, GE Healthcare (2013) Summary page 20.

## Most influential descendants
- K170277: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System (2017), 20 descendants of its own
- K160381: TE7 Diagnostic Ultrasound System (2016), 13 descendants of its own
- K171034: M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System (2017), 12 descendants of its own
- K161525: TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System (2016), 12 descendants of its own
- K180912: TE7/TE5 Diagnostic Ultrasound System (2018), 11 descendants of its own

## Indications for use
The M9/M9CV/M9T 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, trans-esoph. (Cardiac), peripheral vessel , urology exams.

Source page: https://510kreport.com/device/K152543
Methodology: https://510kreport.com/methodology