# K172860: Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jan 2, 2018 after 104 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: 26 generations back to K935595 (1995). 238 ancestors in all.
No later device cites it as a predicate yet.
0 of 239 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171233: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System, Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. (2017) Summary page 4.

## Indications for use
The Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite 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), adult and pediatric cardiac, peripheral vessel, urology exam.

Source page: https://510kreport.com/device/K172860
Methodology: https://510kreport.com/methodology