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FDA 510(k)

Scenium

K-Number: K162339 · 2016-09-21

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2016-09-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Scenium 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 2016-09-21 under 510(k) number K162339. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Scenium?

Scenium is a medical device that received FDA 510(k) clearance on 2016-09-21. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K162339.

When did Scenium receive FDA 510(k) clearance?

Scenium received FDA 510(k) clearance on 2016-09-21, under 510(k) number K162339.

Who is the listed applicant for Scenium?

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 Scenium?

The FDA product code for Scenium is LLZ.

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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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