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FDA 510(k)

ARTISTE SOLUTION WITH SYS_VB50 UPDATE

K-Number: K103606 · 2011-04-15

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2011-04-15
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ARTISTE SOLUTION WITH SYS_VB50 UPDATE 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 2011-04-15 under 510(k) number K103606. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTISTE SOLUTION WITH SYS_VB50 UPDATE?

ARTISTE SOLUTION WITH SYS_VB50 UPDATE is a medical device that received FDA 510(k) clearance on 2011-04-15. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K103606.

When did ARTISTE SOLUTION WITH SYS_VB50 UPDATE receive FDA 510(k) clearance?

ARTISTE SOLUTION WITH SYS_VB50 UPDATE received FDA 510(k) clearance on 2011-04-15, under 510(k) number K103606.

Who is the listed applicant for ARTISTE SOLUTION WITH SYS_VB50 UPDATE?

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 ARTISTE SOLUTION WITH SYS_VB50 UPDATE?

The FDA product code for ARTISTE SOLUTION WITH SYS_VB50 UPDATE is IYE.

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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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