# K222754: ViewMate Multi Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
- Decided: Nov 9, 2022 after 58 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). 384 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 386 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210699: Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2021) Summary page 5.
- K192410: ZS3 and z.one pro Ultrasound Systems, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2019) Summary page 5.

## Most influential descendants
- K251250: ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02) (2025), 0 descendants of its own

## Indications for use
ViewMate Multi Ultrasound System VMM-ICE-01 is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Abdominal, Intra-operative (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. 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/K222754
Methodology: https://510kreport.com/methodology