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FDA 510(k)

syngo.via MI Workflows; Scenium; syngo MBF

K-Number: K251528 · 2025-07-03

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2025-07-03
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo.via MI Workflows; Scenium; syngo MBF is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2025-07-03 under approval number K251528. 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 2025-07-03. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K251528.

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

syngo.via MI Workflows; Scenium; syngo MBF received FDA 510(k) clearance on 2025-07-03, under approval number K251528.

What company makes syngo.via MI Workflows; Scenium; syngo MBF?

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

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.

Other Devices by Siemens Medical Solutions USA, Inc.

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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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