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FDA 510(k)

VXvue

K-Number: K251410 · 2025-11-04

Decision Date2025-11-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VXvue is the device name listed in this FDA 510(k) record. The listed applicant is Vieworks Co., Ltd.. It received FDA 510(k) clearance on 2025-11-04 under 510(k) 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. The listed applicant is Vieworks Co., Ltd.. The 510(k) number is K251410.

When did VXvue receive FDA 510(k) clearance?

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

Who is the listed applicant for VXvue?

The FDA 510(k) record lists Vieworks Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VXvue?

The FDA product code for VXvue is LLZ.

Other records listing Vieworks Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 14 devices →

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.