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FDA 510(k)

AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM

K-Number: K010721 · 2001-03-30

ApplicantSiemens Medical Corp.
Decision Date2001-03-30
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Corp.. It received FDA 510(k) clearance on 2001-03-30 under 510(k) number K010721. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM?

AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 2001-03-30. The listed applicant is Siemens Medical Corp.. The 510(k) number is K010721.

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

AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM received FDA 510(k) clearance on 2001-03-30, under 510(k) number K010721.

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

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

What is the FDA product code for AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM?

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

Related Clinical Trials

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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Other records listing Siemens Medical Corp. 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.

K012202NUMARIS 4VA15AK994231SIEMENS INTEGRATED OPERATING SYSTEM (SIOS)K994316MAGNETOM OPEN VIVA WITH PERMANENT MAGNETK9846343D-ANGIO

Related Devices (Code: IZI)

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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