# K143472: TE7 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jan 2, 2015 after 28 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: 22 generations back to K935595 (1995). 199 ancestors in all.
38 later devices descend from it; 3 cite it directly.
0 of 238 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 6.
- K131690: M7/M7T Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2013) Summary page 7.

## Most influential descendants
- K152543: M9/M9CV/M9T Diagnostic Ultrasound System (2015), 35 descendants of its own
- 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

## Indications for use
TE7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal,Intra-operative(abdominal, thoracic, and vascular) ,Pediatric,small organ(breast, thyroid, testes), neonatal and adult cephalic,trans-esoph. (Cardiac), trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), urology,Peripheral vessel, Adult and Pediatric cardiac exams.

Source page: https://510kreport.com/device/K143472
Methodology: https://510kreport.com/methodology