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FDA 510(k)

Syngo Carbon Clinicals (VA41)

K-Number: K251059 · 2025-10-24

ApplicantSiemens Healthineers AG
Decision Date2025-10-24
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Syngo Carbon Clinicals (VA41) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthineers AG. It received FDA 510(k) clearance on 2025-10-24 under 510(k) 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. The listed applicant is Siemens Healthineers AG. The 510(k) number is K251059.

When did Syngo Carbon Clinicals (VA41) receive FDA 510(k) clearance?

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

Who is the listed applicant for Syngo Carbon Clinicals (VA41)?

The FDA 510(k) record lists Siemens Healthineers AG as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Siemens Healthineers AG as applicant

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Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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