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FDA 510(k)

SOMATOM Drive

K-Number: K161196 · 2016-08-24

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2016-08-24
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOMATOM Drive 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 2016-08-24 under 510(k) number K161196. 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 Drive?

SOMATOM Drive is a medical device that received FDA 510(k) clearance on 2016-08-24. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K161196.

When did SOMATOM Drive receive FDA 510(k) clearance?

SOMATOM Drive received FDA 510(k) clearance on 2016-08-24, under 510(k) number K161196.

Who is the listed applicant for SOMATOM Drive?

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 Drive?

The FDA product code for SOMATOM Drive 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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