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FDA 510(k)

syngo.via MI Workflows, syngo MBF

K-Number: K201195 · 2020-11-18

Decision Date2020-11-18
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo.via MI Workflows, syngo MBF is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2020-11-18 under approval number K201195. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the syngo.via MI Workflows, syngo MBF?

syngo.via MI Workflows, syngo MBF is a medical device that received FDA 510(k) clearance on 2020-11-18. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K201195.

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

syngo.via MI Workflows, syngo MBF received FDA 510(k) clearance on 2020-11-18, under approval number K201195.

What company makes syngo.via MI Workflows, syngo MBF?

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

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

The FDA product code for syngo.via MI Workflows, syngo MBF is QIH.

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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.