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FDA 510(k)

syngo.via MI WorkFlows, Scenium, syngo MBF

K-Number: K211459 · 2021-06-10

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2021-06-10
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo.via MI WorkFlows, Scenium, syngo MBF 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 2021-06-10 under 510(k) number K211459. 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, Scenium, syngo MBF?

syngo.via MI WorkFlows, Scenium, syngo MBF is a medical device that received FDA 510(k) clearance on 2021-06-10. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K211459.

When did syngo.via MI WorkFlows, Scenium, syngo MBF receive FDA 510(k) clearance?

syngo.via MI WorkFlows, Scenium, syngo MBF received FDA 510(k) clearance on 2021-06-10, under 510(k) number K211459.

Who is the listed applicant for syngo.via MI WorkFlows, Scenium, syngo MBF?

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.via MI WorkFlows, Scenium, syngo MBF?

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

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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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