# K150080: DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jun 12, 2015 after 148 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: 22 generations back to K935595 (1995). 210 ancestors in all.
79 later devices descend from it; 7 cite it directly.
0 of 290 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132341: DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound Systems, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2013) Summary page 4.
- K141010: M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2014) Summary page 30.
- K132913: Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10, GE Healthcare (2013) Summary page 30.

## Most influential descendants
- K152763: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (2015), 65 descendants of its own
- K162267: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (2016), 53 descendants of its own
- K152543: M9/M9CV/M9T Diagnostic Ultrasound System (2015), 35 descendants of its own
- K171233: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (2017), 21 descendants of its own
- K170277: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System (2017), 20 descendants of its own

## Indications for use
The DC-8/DC-8 PRO/DC-8 CV/DC-8S/DC-8 EXP 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, transvaginal. musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel, urology and transesophageal (cardiac) exams.

Source page: https://510kreport.com/device/K150080
Methodology: https://510kreport.com/methodology