# K183377: 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: Apr 4, 2019 after 119 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). 240 ancestors in all.
No later device cites it as a predicate yet.
0 of 241 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162845: DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2016) Summary page 4.

## 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, peripheral vessel and urology exams.

Source page: https://510kreport.com/device/K183377
Methodology: https://510kreport.com/methodology