syngo.CT Skull Unfolding
K-Number: K203411 · 2021-07-22
ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2021-07-22
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
syngo.CT Skull Unfolding is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2021-07-22 under approval number K203411. 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 Skull Unfolding?
syngo.CT Skull Unfolding is a medical device that received FDA 510(k) clearance on 2021-07-22. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K203411.
When was syngo.CT Skull Unfolding approved by the FDA?
syngo.CT Skull Unfolding received FDA 510(k) clearance on 2021-07-22, under approval number K203411.
What company makes syngo.CT Skull Unfolding?
syngo.CT Skull Unfolding is manufactured by Siemens Medical Solutions USA, Inc..
What is the FDA product code for syngo.CT Skull Unfolding?
The FDA product code for syngo.CT Skull Unfolding 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.