FastStroke, CT Perfusion 4D
K-Number: K193289 · 2020-11-12
ApplicantGE Medical Systems SCS
Decision Date2020-11-12
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
FastStroke, CT Perfusion 4D is a medical device manufactured by GE Medical Systems SCS. It received FDA 510(k) clearance on 2020-11-12 under approval number K193289. 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 FastStroke, CT Perfusion 4D?
FastStroke, CT Perfusion 4D is a medical device that received FDA 510(k) clearance on 2020-11-12. It is manufactured by GE Medical Systems SCS. The 510(k) number is K193289.
When was FastStroke, CT Perfusion 4D approved by the FDA?
FastStroke, CT Perfusion 4D received FDA 510(k) clearance on 2020-11-12, under approval number K193289.
What company makes FastStroke, CT Perfusion 4D?
FastStroke, CT Perfusion 4D is manufactured by GE Medical Systems SCS.
What is the FDA product code for FastStroke, CT Perfusion 4D?
The FDA product code for FastStroke, CT Perfusion 4D 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.