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FDA 510(k)

syngo.via MI Workflows

K-Number: K160426 · 2016-03-04

Decision Date2016-03-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo.via MI Workflows is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2016-03-04 under approval number K160426. 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 MI Workflows?

syngo.via MI Workflows is a medical device that received FDA 510(k) clearance on 2016-03-04. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K160426.

When was syngo.via MI Workflows approved by the FDA?

syngo.via MI Workflows received FDA 510(k) clearance on 2016-03-04, under approval number K160426.

What company makes syngo.via MI Workflows?

syngo.via MI Workflows is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for syngo.via MI Workflows?

The FDA product code for syngo.via MI Workflows 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.