# K123185: 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: Nov 2, 2012 after 23 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). 185 ancestors in all.
97 later devices descend from it; 1 cites it directly.
0 of 283 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113647: DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S 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.
- K110199: DC-T6 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2011) Summary page 2.
- K122010: Z6 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2012) Summary page 2.
- K112596: Acuson S2000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc., Ultrasound DI (2011) Summary page 2.
- K050034: Sonoline Antares Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2005) Summary page 2.

## Cited in the summary but kept off the family tree
- K101041: DC-7 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
- K150080: DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S (2015), 79 descendants of its own
- K150204: DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems (2015), 71 descendants of its own
- K152763: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (2015), 65 descendants of its own

## Indications for use
The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-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/K123185
Methodology: https://510kreport.com/methodology