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FDA 510(k)

ViewMateTM Ultrasound System

K-Number: K251820 · 2025-09-12

Decision Date2025-09-12
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ViewMateTM Ultrasound System is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-09-12 under approval number K251820. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ViewMateTM Ultrasound System?

ViewMateTM Ultrasound System is a medical device that received FDA 510(k) clearance on 2025-09-12. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K251820.

When was ViewMateTM Ultrasound System approved by the FDA?

ViewMateTM Ultrasound System received FDA 510(k) clearance on 2025-09-12, under approval number K251820.

What company makes ViewMateTM Ultrasound System?

ViewMateTM Ultrasound System is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..

What is the FDA product code for ViewMateTM Ultrasound System?

The FDA product code for ViewMateTM Ultrasound System is IYN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.