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FDA 510(k)

VXvue

K-Number: K251410 · 2025-11-04

ApplicantVieworks Co., Ltd.
Decision Date2025-11-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VXvue is a medical device manufactured by Vieworks Co., Ltd.. It received FDA 510(k) clearance on 2025-11-04 under approval number K251410. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VXvue?

VXvue is a medical device that received FDA 510(k) clearance on 2025-11-04. It is manufactured by Vieworks Co., Ltd.. The 510(k) number is K251410.

When was VXvue approved by the FDA?

VXvue received FDA 510(k) clearance on 2025-11-04, under approval number K251410.

What company makes VXvue?

VXvue is manufactured by Vieworks Co., Ltd..

What is the FDA product code for VXvue?

The FDA product code for VXvue is LLZ.

Other Devices by Vieworks Co., Ltd.

K161113QXLink K152894VIVIX-S 1717N K152855VIVIX-S 1012N K163703VIVIX-S 1417N K181003VIVIX-S 1717V K190611VIVIX-S 1751S

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Official Source

View on FDA Database →

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

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