FDA 510(k)

Syngo Carbon Clinicals (VA41)

K-Number: K251059 · 2025-10-24

Decision Date2025-10-24

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Syngo Carbon Clinicals (VA41) is a medical device manufactured by Siemens Healthineers AG. It received FDA 510(k) clearance on 2025-10-24 under approval number K251059. 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 Carbon Clinicals (VA41)?

Syngo Carbon Clinicals (VA41) is a medical device that received FDA 510(k) clearance on 2025-10-24. It is manufactured by Siemens Healthineers AG. The 510(k) number is K251059.

When was Syngo Carbon Clinicals (VA41) approved by the FDA?

Syngo Carbon Clinicals (VA41) received FDA 510(k) clearance on 2025-10-24, under approval number K251059.

What company makes Syngo Carbon Clinicals (VA41)?

Syngo Carbon Clinicals (VA41) is manufactured by Siemens Healthineers AG.

What is the FDA product code for Syngo Carbon Clinicals (VA41)?

The FDA product code for Syngo Carbon Clinicals (VA41) 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.