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FDA 510(k)

Syngo Carbon Clinicals

K-Number: K232856 · 2023-12-01

ApplicantSiemens Healthcare GmbH
Decision Date2023-12-01
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Syngo Carbon Clinicals is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K232856. 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?

Syngo Carbon Clinicals is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is Siemens Healthcare GmbH. The 510(k) number is K232856.

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

Syngo Carbon Clinicals received FDA 510(k) clearance on 2023-12-01, under 510(k) number K232856.

Who is the listed applicant for Syngo Carbon Clinicals?

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

What is the FDA product code for Syngo Carbon Clinicals?

The FDA product code for Syngo Carbon Clinicals 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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