# K162845: DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Dec 15, 2016 after 65 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: 25 generations back to K935595 (1995). 239 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 241 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140030: DC-N3/DC-N3S Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2014) Summary page 13.
- K152545: DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2015) Summary page 13.
- K162267: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2016) Summary page 13.

## Most influential descendants
- K183377: DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System (2019), 0 descendants of its own

## Indications for use
The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro 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 cephalic,adult cephalic,trans-rectal, trans-vaginal, musculo-skeletal(conventional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric and peripheral vessel exams.

Source page: https://510kreport.com/device/K162845
Methodology: https://510kreport.com/methodology