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FDA 510(k)

MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS

K-Number: K021021 · 2002-06-06

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2002-06-06
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS 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 2002-06-06 under 510(k) number K021021. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS?

MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS is a medical device that received FDA 510(k) clearance on 2002-06-06. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K021021.

When did MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS receive FDA 510(k) clearance?

MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS received FDA 510(k) clearance on 2002-06-06, under 510(k) number K021021.

Who is the listed applicant for MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS?

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 MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS?

The FDA product code for MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS is JAA.

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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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