FDA 510(k)

Helion Viewer Suite

Número K: K254265 · 2026-05-27

RequerenteVideomed Srl ( a Baxter Healthcare Corp company)

Data da decisão2026-05-27

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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