# K180912: TE7/TE5 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jul 30, 2018 after 115 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: 26 generations back to K935595 (1995). 248 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 260 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161525: TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2016) Summary page 4.

## Most influential descendants
- K203391: TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System (2021), 7 descendants of its own
- K212265: TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System (2021), 6 descendants of its own
- K220051: TE Air Diagnostic Ultrasound System (2022), 3 descendants of its own
- K231685: TE Air Diagnostic Ultrasound System (2023), 2 descendants of its own
- K240906: TE Air Diagnostic Ultrasound System (2024), 1 descendant of its own

## Indications for use
TE7/TE5 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, ophthalmic exams.

Source page: https://510kreport.com/device/K180912
Methodology: https://510kreport.com/methodology