# K182636: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jan 10, 2019 after 108 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: 24 generations back to K935595 (1995). 217 ancestors in all.
No later device cites it as a predicate yet.
0 of 218 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152545: DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2015) Summary page 25.

## Indications for use
DC-60/DC-60S/DC-60 Exp/DC-55 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, peripheral vessel and urology exam.

Source page: https://510kreport.com/device/K182636
Methodology: https://510kreport.com/methodology