# K063500: DC-6 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Dec 6, 2006 after 16 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: 9 generations back to K935595 (1995). 62 ancestors in all.
189 later devices descend from it; 1 cites it directly.
0 of 252 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010631: NEMIO, Toshiba America Medical Systems, In.C (2001) Summary page 1.
- K051500: Famio Diagnostic Ultrasound Systems, Model Ssa-530A, Toshiba America Medical Systems, In.C (2005) Summary page 1.
- K012080: SSD-5000 Diagnostic Ultrasound System, Aloka Co., Ltd. (2001) Summary page 1.
- K042540: Philips IU22 Ultrasound System, Philips Ultrasound, Inc. (2004) Summary page 1.
- K052894: Sonoline G60 S Ultrasound System, Siemens Medical Solutions USA, Inc. (2005) Summary page 1.
- K052410: Acuson Sequoia Ultrasound System, Siemens Medical Solutions USA, Inc. (2005) Summary page 1.
- K061189: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2006) Summary page 1.

## Most influential descendants
- 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
- K083001: M5 Diagnostic Ultrasound System (2008), 179 descendants of its own
- K083505: DC-3/DC-3T Diagnostic Ultrasound System (2008), 178 descendants of its own

## Indications for use
The device is intended for use by a qualified physician for ultrasound evaluation of adult abdomen, adult cardiology, pediatric abdomen, pediatric cardiology, fetal cardiology, gynecology, obstetrics (first trimester, second and third trimester), kidney, prostate, thyroid, breast, and other small parts, and peripheral vascular (peripheral artery and peripheral vein), and carotid scanning.

Source page: https://510kreport.com/device/K063500
Methodology: https://510kreport.com/methodology