# K070526: DP-9900 Digital Ultrasonic Diagnostic Imaging System

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Mar 23, 2007 after 28 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: 9 generations back to K935595 (1995). 32 ancestors in all.
117 later devices descend from it; 2 cite it directly.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043563: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2005) Summary page 2.
- K053346: Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model DP-9900, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2005) Summary page 2.
- K061189: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2006) Summary page 2.
- K010631: NEMIO, Toshiba America Medical Systems, In.C (2001) Summary page 2.
- K992663: Aloka SSD-5500 Diagnostic Ultrasound System, Aloka Co., Ltd. (1999) Summary page 2.

## Most influential descendants
- K090912: Digital Ultrasonic Diagnostic Imaging System, Model DP-6900 (2009), 114 descendants of its own
- K122010: Z6 Diagnostic Ultrasound System (2012), 109 descendants of its own
- K123185: DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound System (2012), 97 descendants of its own
- K132341: DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound Systems (2013), 96 descendants of its own
- K141010: M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System (2014), 83 descendants of its own

## Indications for use
The DP-9900 Digital Ultrasonic Diagnostic Imaging System with added transducer is a general-purpose, fully digital ultrasound system for abdominal, gynecologic and obstetric, small parts, and cardiac applications. The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal, peripheral vascular, and musculo-skeletal (both conventional and superficial). This device is intended to adult, pregnant woman, pediatric and neonate. The Device is a prescription device intended to be used by or on the order of a physician or similarly qualified health care professional. This Device is not intended for home use.

Source page: https://510kreport.com/device/K070526
Methodology: https://510kreport.com/methodology