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FDA 510(k)

syngo Application Software

K-Number: K162541 · 2016-11-16

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2016-11-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo Application Software 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 2016-11-16 under 510(k) number K162541. 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?

syngo Application Software is a medical device that received FDA 510(k) clearance on 2016-11-16. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K162541.

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

syngo Application Software received FDA 510(k) clearance on 2016-11-16, under 510(k) number K162541.

Who is the listed applicant for syngo Application Software?

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?

The FDA product code for syngo Application Software is LLZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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