# K152763: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Oct 21, 2015 after 27 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: 23 generations back to K935595 (1995). 233 ancestors in all.
65 later devices descend from it; 2 cite it directly.
0 of 299 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150080: DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2015) Summary page 17.
- K141010: M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2014) Summary page 17.
- K150204: DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2015) Summary page 17.
- K132335: Ultrasound Scanner Flex Focus 1202, B-K Medical Aps (2014) Summary page 17.
- K132913: Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10, GE Healthcare (2013) Summary page 17.
- K142160: Logiq E9 Diagnostic Ultrasound System, GE Healthcare (2014) Summary page 17.

## Most influential descendants
- K162267: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (2016), 53 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
- K171034: M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System (2017), 12 descendants of its own
- K161525: TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System (2016), 12 descendants of its own

## Indications for use
The Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB 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/K152763
Methodology: https://510kreport.com/methodology