# K113647: DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Dec 16, 2011 after 4 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: 18 generations back to K935595 (1995). 180 ancestors in all.
116 later devices descend from it; 4 cite it directly.
0 of 297 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103583: DC-7 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.
- K101236: Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/ H48681BX/ H48681BM, GE Healthcare (2011) Summary page 2.
- K110199: DC-T6 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2011)
- K101757: Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound System, Sonosite,Inc. (2010) Summary page 2.
- K112596: Acuson S2000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc., Ultrasound DI (2011) Summary page 2.
- K063085: Modification to Acuson Sequoia Ultrasound System, Siemens Medical Solutions USA, Inc. (2006) Summary page 2.
- K102256: GE Logiq I/E & Vivid E Compact Diagnostic Ultrasound, Ge Medical Systems China Co., Ltd. (2010) Summary page 2.

## Most influential descendants
- K121010: M7/M7T Diagnostic Ultrasound System (2012), 107 descendants of its own
- K120699: DC-T6 Diagnostic Ultrasound System (2012), 103 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
- K131690: M7/M7T Diagnostic Ultrasound System (2013), 92 descendants of its own

## Indications for use
The DC-B/DC-B PRO/DC-8 CV/DC-B EXPIDC-8S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

Source page: https://510kreport.com/device/K113647
Methodology: https://510kreport.com/methodology