# K251192: Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Aug 22, 2025 after 127 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: 30 generations back to K935595 (1995). 360 ancestors in all.
No later device cites it as a predicate yet.
6 of 361 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241432: MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2024) Summary page 6.

## Indications for use
The MX7/MX7T/NVaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8/Nuda/Aquila/Malody Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in ophthalmic, fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic,adult cephalic,trans-rectal, trans-vaginal, musculo-skeletal(conventional), musculo-skeletal(superficial), thoracic/pleural, cardiac adult, cardiac pediatric, peripheral vessel and urology, intra-operative(abdominal, thoracic, and vascular) , Laparoscopic, trans-esoph(Cardiac) exams. Modes of operation include: B, M, PWD, CWD, Color Doppler, Power Doppler, Combined mode(B+M, PW +B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver). 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.

Source page: https://510kreport.com/device/K251192
Methodology: https://510kreport.com/methodology