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FDA 510(k)

syngo Application Software

K-Number: K254184 · 2026-04-29

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2026-04-29
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo Application Software is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2026-04-29 under approval number K254184. 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 Application Software?

syngo Application Software is a medical device that received FDA 510(k) clearance on 2026-04-29. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K254184.

When was syngo Application Software approved by the FDA?

syngo Application Software received FDA 510(k) clearance on 2026-04-29, under approval number K254184.

What company makes syngo Application Software?

syngo Application Software is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for syngo Application Software?

The FDA product code for syngo Application Software is QIH.

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Official Source

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