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FDA 510(k)

ARTIS icono

K-Number: K190768 · 2019-09-12

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2019-09-12
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ARTIS icono 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 2019-09-12 under 510(k) number K190768. 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?

ARTIS icono is a medical device that received FDA 510(k) clearance on 2019-09-12. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K190768.

When did ARTIS icono receive FDA 510(k) clearance?

ARTIS icono received FDA 510(k) clearance on 2019-09-12, under 510(k) number K190768.

Who is the listed applicant for ARTIS icono?

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?

The FDA product code for ARTIS icono 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.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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