# K113153: DP-20 and DP-30  Digital Ultrasonic Diagnostic Imaging System

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Nov 28, 2011 after 34 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K935595 (1995). 170 ancestors in all.
76 later devices descend from it; 2 cite it directly.
0 of 247 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090912: Digital Ultrasonic Diagnostic Imaging System, Model DP-6900, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2009) Summary page 2.
- K102991: M5 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2010) Summary page 2.
- K103677: M7/M7T Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2011) Summary page 2.

## Most influential descendants
- K130695: Z5 Diagnostic Ultrasound System (2013), 74 descendants of its own
- K132779: DC-N2/DC-N2S Diagnostic Ultrasound System (2013), 72 descendants of its own
- K150204: DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems (2015), 71 descendants of its own
- K152763: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (2015), 65 descendants of its own
- K162267: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (2016), 53 descendants of its own

## Indications for use
The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intraoperative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular and urology exams.

Source page: https://510kreport.com/device/K113153
Methodology: https://510kreport.com/methodology