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 a medical device manufactured by Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2023-12-01 under approval 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. It is manufactured by Siemens Healthcare GmbH. The 510(k) number is K232856.
When was Syngo Carbon Clinicals approved by the FDA?
Syngo Carbon Clinicals received FDA 510(k) clearance on 2023-12-01, under approval number K232856.
What company makes Syngo Carbon Clinicals?
Syngo Carbon Clinicals is manufactured by Siemens Healthcare GmbH.
What is the FDA product code for Syngo Carbon Clinicals?
The FDA product code for Syngo Carbon Clinicals is QIH.
Other Devices by Siemens Healthcare GmbH
Related Devices (Code: QIH)
K191647QLAB Advanced Quantification SoftwarePhilips Health Care
K191171EchoGo CoreUltromics, Ltd.
K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.
K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.
K202546LVivo SeamlessDia Imaging Analysis, Ltd.
K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.
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.