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FDA 510(k)

ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno

K-Number: K254173 · 2026-04-24

Decision Date2026-04-24
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2026-04-24 under approval number K254173. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno?

ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno is a medical device that received FDA 510(k) clearance on 2026-04-24. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K254173.

When was ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno approved by the FDA?

ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno received FDA 510(k) clearance on 2026-04-24, under approval number K254173.

What company makes ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno?

ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno?

The FDA product code for ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno is OWB.

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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.