syngo.CT Lung CAD
K-Number: K203258 · 2021-03-31
ApplicantSiemens Healthcare GmbH
Decision Date2021-03-31
Product CodeOEB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
syngo.CT Lung CAD is a medical device manufactured by Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2021-03-31 under approval number K203258. The device is classified under product code OEB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the syngo.CT Lung CAD?
syngo.CT Lung CAD is a medical device that received FDA 510(k) clearance on 2021-03-31. It is manufactured by Siemens Healthcare GmbH. The 510(k) number is K203258.
When was syngo.CT Lung CAD approved by the FDA?
syngo.CT Lung CAD received FDA 510(k) clearance on 2021-03-31, under approval number K203258.
What company makes syngo.CT Lung CAD?
syngo.CT Lung CAD is manufactured by Siemens Healthcare GmbH.
What is the FDA product code for syngo.CT Lung CAD?
The FDA product code for syngo.CT Lung CAD is OEB.
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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.