# K113632: DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic Imaging System

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
- Decided: Jan 25, 2012 after 51 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: 19 generations back to K935595 (1995). 172 ancestors in all.
No later device cites it as a predicate yet.
0 of 173 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.
- K111435: DP-50 Digital Ultrasonic Diagnostic Imaging System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2011) 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.
- K103583: DC-7 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2010) Summary page 2.

## Indications for use
The DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic,, trans-rectal, trans-vaginal, musculo-skeletal, pediatric cardiac, adult cardiac(only for DP-7), peripheral vessel and urology exams.

Source page: https://510kreport.com/device/K113632
Methodology: https://510kreport.com/methodology