# K053346: Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model DP-9900

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Dec 9, 2005 after 7 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: 7 generations back to K935595 (1995). 27 ancestors in all.
194 later devices descend from it; 2 cite it directly.
0 of 222 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.
- K051500: Famio Diagnostic Ultrasound Systems, Model Ssa-530A, Toshiba America Medical Systems, In.C (2005) Summary page 2.

## Most influential descendants
- K061189: DP-9900 Digital Ultrasonic Diagnostic Imaging System (2006), 193 descendants of its own
- K063500: DC-6 Diagnostic Ultrasound System (2006), 189 descendants of its own
- K072164: DC-6 Diagnostic Ultrasound System (2007), 188 descendants of its own
- K080640: M5 Diagnostic Ultrasound System (2008), 182 descendants of its own
- K081320: DC-3, DC-3T Diagnostic Ultrasound System (2008), 180 descendants of its own

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K053346
Methodology: https://510kreport.com/methodology