# K162267: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Sep 6, 2016 after 26 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: 24 generations back to K935595 (1995). 236 ancestors in all.
53 later devices descend from it; 5 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)
- K152763: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2015) Summary page 4.
- K150080: DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2015) Summary page 19.
- K152567: Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System, GE Healthcare (2015) Summary page 19.

## Most influential descendants
- 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
- K171034: M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System (2017), 12 descendants of its own
- K163690: DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System (2017), 9 descendants of its own
- K200001: MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System (2020), 8 descendants of its own

## Indications for use
The Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B 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), 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/K162267
Methodology: https://510kreport.com/methodology