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FDA 510(k)

Artis zee/zeego & Artis Q/Q.zen

K-Number: K181407 · 2018-08-15

ApplicantSiemens Medical Solution USA, Inc.
Decision Date2018-08-15
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Artis zee/zeego & Artis Q/Q.zen is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solution USA, Inc.. It received FDA 510(k) clearance on 2018-08-15 under 510(k) number K181407. 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 zee/zeego & Artis Q/Q.zen?

Artis zee/zeego & Artis Q/Q.zen is a medical device that received FDA 510(k) clearance on 2018-08-15. The listed applicant is Siemens Medical Solution USA, Inc.. The 510(k) number is K181407.

When did Artis zee/zeego & Artis Q/Q.zen receive FDA 510(k) clearance?

Artis zee/zeego & Artis Q/Q.zen received FDA 510(k) clearance on 2018-08-15, under 510(k) number K181407.

Who is the listed applicant for Artis zee/zeego & Artis Q/Q.zen?

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

What is the FDA product code for Artis zee/zeego & Artis Q/Q.zen?

The FDA product code for Artis zee/zeego & Artis Q/Q.zen is OWB.

Other records listing Siemens Medical Solution USA, Inc. as applicant

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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.K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens 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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