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FDA 510(k)

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

K-Number: K254173 · 2026-04-24

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2026-04-24
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2026-04-24 under 510(k) 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. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K254173.

When did ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno receive FDA 510(k) clearance?

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

Who is the listed applicant for ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: OWB)

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.

K254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.K252503Intelligent NRCanon, Inc.K253752ARTIS genio floor; ARTIS icono.explore floorSiemens Medical Solutions USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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