FDA 510(k)

AS Software Version Asera

K-Number: K260205 · 2026-02-19

Decision Date2026-02-19

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AS Software Version Asera is the device name listed in this FDA 510(k) record. The listed applicant is AS Software, LLC. It received FDA 510(k) clearance on 2026-02-19 under 510(k) number K260205. 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 AS Software Version Asera?

AS Software Version Asera is a medical device that received FDA 510(k) clearance on 2026-02-19. The listed applicant is AS Software, LLC. The 510(k) number is K260205.

When did AS Software Version Asera receive FDA 510(k) clearance?

AS Software Version Asera received FDA 510(k) clearance on 2026-02-19, under 510(k) number K260205.

Who is the listed applicant for AS Software Version Asera?

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

What is the FDA product code for AS Software Version Asera?

The FDA product code for AS Software Version Asera 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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, 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.