FDA 510(k)

Helion Viewer Suite

K-Number: K254265 · 2026-05-27

ApplicantVideomed Srl ( a Baxter Healthcare Corp company)

Decision Date2026-05-27

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Helion Viewer Suite is the device name listed in this FDA 510(k) record. The listed applicant is Videomed Srl ( a Baxter Healthcare Corp company). It received FDA 510(k) clearance on 2026-05-27 under 510(k) number K254265. 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 Helion Viewer Suite?

Helion Viewer Suite is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is Videomed Srl ( a Baxter Healthcare Corp company). The 510(k) number is K254265.

When did Helion Viewer Suite receive FDA 510(k) clearance?

Helion Viewer Suite received FDA 510(k) clearance on 2026-05-27, under 510(k) number K254265.

Who is the listed applicant for Helion Viewer Suite?

The FDA 510(k) record lists Videomed Srl ( a Baxter Healthcare Corp company) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Helion Viewer Suite?

The FDA product code for Helion Viewer Suite 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.