# K260846: Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: May 11, 2026 after 56 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: 31 generations back to K935595 (1995). 361 ancestors in all.
No later device cites it as a predicate yet.
6 of 362 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251853: Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2025) Summary page 6.

## Indications for use
MU9, MUSS, MU9T, MU9 Exp, MU9 Pro, MU9 Super, MU9P, MU9SA, MU7, MU7S, MU7T, MU7 Exp, MU7 Pro, MU7 Super, MU7P, MU7A 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, trans-vaginal, musculoskeletal(conventional), musculo-skeletal(superficial), thoracic/pleural, cardiac adult, cardiac pediatric, 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(Color+B, Power+B), Tissue Harmonic Imaging, iScape View, TDI.

Source page: https://510kreport.com/device/K260846
Methodology: https://510kreport.com/methodology