FDA 510(k)

syngo®.via protoNeo (Version VA10A)

K-Number: K161685 · 2016-07-11

Decision Date2016-07-11

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

syngo®.via protoNeo (Version VA10A) is a medical device manufactured by Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2016-07-11 under approval number K161685. 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®.via protoNeo (Version VA10A)?

syngo®.via protoNeo (Version VA10A) is a medical device that received FDA 510(k) clearance on 2016-07-11. It is manufactured by Siemens Healthcare GmbH. The 510(k) number is K161685.

When was syngo®.via protoNeo (Version VA10A) approved by the FDA?

syngo®.via protoNeo (Version VA10A) received FDA 510(k) clearance on 2016-07-11, under approval number K161685.

What company makes syngo®.via protoNeo (Version VA10A)?

syngo®.via protoNeo (Version VA10A) is manufactured by Siemens Healthcare GmbH.

What is the FDA product code for syngo®.via protoNeo (Version VA10A)?

The FDA product code for syngo®.via protoNeo (Version VA10A) is LLZ.

Other Devices by Siemens Healthcare GmbH

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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.