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FDA 510(k)

SOMATOM DEFINITION AS

K-Number: K103127 · 2011-03-04

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2011-03-04
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOMATOM DEFINITION AS 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 2011-03-04 under 510(k) number K103127. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOMATOM DEFINITION AS?

SOMATOM DEFINITION AS is a medical device that received FDA 510(k) clearance on 2011-03-04. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K103127.

When did SOMATOM DEFINITION AS receive FDA 510(k) clearance?

SOMATOM DEFINITION AS received FDA 510(k) clearance on 2011-03-04, under 510(k) number K103127.

Who is the listed applicant for SOMATOM DEFINITION AS?

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 SOMATOM DEFINITION AS?

The FDA product code for SOMATOM DEFINITION AS is JAK.

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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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