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FDA 510(k)

ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM

K-Number: K123529 · 2013-02-26

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2013-02-26
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM 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 2013-02-26 under 510(k) number K123529. 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 Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM?

ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM is a medical device that received FDA 510(k) clearance on 2013-02-26. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K123529.

When did ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM receive FDA 510(k) clearance?

ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM received FDA 510(k) clearance on 2013-02-26, under 510(k) number K123529.

Who is the listed applicant for ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM?

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 Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM?

The FDA product code for ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM is OWB.

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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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