FDA 510(k)

AdvaView

K-Number: K262449 · 2026-08-14

Decision Date2026-08-14

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AdvaView is the device name listed in this FDA 510(k) record. The listed applicant is ADVAHEALTH SOLUTIONS, LLC. It received FDA 510(k) clearance on 2026-08-14 under 510(k) number K262449. 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 AdvaView?

AdvaView is a medical device that received FDA 510(k) clearance on 2026-08-14. The listed applicant is ADVAHEALTH SOLUTIONS, LLC. The 510(k) number is K262449.

When did AdvaView receive FDA 510(k) clearance?

AdvaView received FDA 510(k) clearance on 2026-08-14, under 510(k) number K262449.

Who is the listed applicant for AdvaView?

The FDA 510(k) record lists ADVAHEALTH SOLUTIONS, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AdvaView?

The FDA product code for AdvaView is LLZ.

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.

K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, Inc.K260500ResolutionMDResolutionMD, Inc.

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.