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FDA 510(k)

Zenition 30

K-Number: K254205 · 2026-08-07

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2026-08-07
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Zenition 30 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2026-08-07 under 510(k) number K254205. 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 Zenition 30?

Zenition 30 is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K254205.

When did Zenition 30 receive FDA 510(k) clearance?

Zenition 30 received FDA 510(k) clearance on 2026-08-07, under 510(k) number K254205.

Who is the listed applicant for Zenition 30?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zenition 30?

The FDA product code for Zenition 30 is OWB.

Other records listing Philips Medical Systems Nederland B.V. as applicant

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.

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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.

K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.K252503Intelligent NRCanon, Inc.K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, 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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