Revolution CT
K-Number: K163213 · 2016-12-16
ApplicantGe Medical Systems, LLC
Decision Date2016-12-16
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Revolution CT is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2016-12-16 under approval number K163213. 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 Revolution CT?
Revolution CT is a medical device that received FDA 510(k) clearance on 2016-12-16. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K163213.
When was Revolution CT approved by the FDA?
Revolution CT received FDA 510(k) clearance on 2016-12-16, under approval number K163213.
What company makes Revolution CT?
Revolution CT is manufactured by Ge Medical Systems, LLC.
What is the FDA product code for Revolution CT?
The FDA product code for Revolution CT is JAK.
Other Devices by Ge Medical Systems, LLC
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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.