# K250020: Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); Diagnost

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: May 19, 2025 after 136 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: 28 generations back to K935595 (1995). 240 ancestors in all.
No later device cites it as a predicate yet.
0 of 241 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222928: Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2023) Summary page 6.

## Indications for use
Recho R9W/Recho R9/Recho R9 Pro/Recho R9 Exp/Recho R9S/Recho R9T/Crius R9 CV/Anesus R9 CV/Recho R9 Super/Recho R9 Lumi/Recho R CV/Recho R CVx Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), thoracic/pleural, adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology exams. This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic. Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, 4D, Matrix 4D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver)

Source page: https://510kreport.com/device/K250020
Methodology: https://510kreport.com/methodology