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FDA 510(k)

syngo Application Software VD11

K-Number: K153346 · 2016-03-04

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2016-03-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo Application Software VD11 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 2016-03-04 under 510(k) number K153346. 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 syngo Application Software VD11?

syngo Application Software VD11 is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K153346.

When did syngo Application Software VD11 receive FDA 510(k) clearance?

syngo Application Software VD11 received FDA 510(k) clearance on 2016-03-04, under 510(k) number K153346.

Who is the listed applicant for syngo Application Software VD11?

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 syngo Application Software VD11?

The FDA product code for syngo Application Software VD11 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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