Syngo.CT CaScoring
K-Number: K201034 · 2020-05-14
ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2020-05-14
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Syngo.CT CaScoring is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2020-05-14 under approval number K201034. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Syngo.CT CaScoring?
Syngo.CT CaScoring is a medical device that received FDA 510(k) clearance on 2020-05-14. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K201034.
When was Syngo.CT CaScoring approved by the FDA?
Syngo.CT CaScoring received FDA 510(k) clearance on 2020-05-14, under approval number K201034.
What company makes Syngo.CT CaScoring?
Syngo.CT CaScoring is manufactured by Siemens Medical Solutions USA, Inc..
What is the FDA product code for Syngo.CT CaScoring?
The FDA product code for Syngo.CT CaScoring is JAK.
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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.