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FDA 510(k)

syngo Application Software

K-Number: K190780 · 2019-09-12

ApplicantSiemens Medical Solution USA, Inc.
Decision Date2019-09-12
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 Solution USA, Inc.. It received FDA 510(k) clearance on 2019-09-12 under 510(k) number K190780. 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 2019-09-12. The listed applicant is Siemens Medical Solution USA, Inc.. The 510(k) number is K190780.

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

syngo Application Software received FDA 510(k) clearance on 2019-09-12, under 510(k) number K190780.

Who is the listed applicant for syngo Application Software?

The FDA 510(k) record lists Siemens Medical Solution 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.

Other records listing Siemens Medical Solution USA, Inc. as applicant

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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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