# K251250: ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Sep 5, 2025 after 135 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: 29 generations back to K935595 (1995). 385 ancestors in all.
No later device cites it as a predicate yet.
6 of 386 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222754: ViewMate Multi Ultrasound System, Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. (2022) Summary page 6.

## Indications for use
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. VMM-ICE-01/VMM-ICE-02 ViewMateTM Multi Ultrascund System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Abdominal, Intraoperative (abdominal, thoracic, and vascular), Pediatric, Small Organ (Thyroid, Breast, Testes), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Intra-cardiac, and Peripheral vessel exams. 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, TDI, Color M.

Source page: https://510kreport.com/device/K251250
Methodology: https://510kreport.com/methodology