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FDA 510(k)

Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

K-Number: K191777 · 2019-07-26

ApplicantGe Medical Systems, LLC
Decision Date2019-07-26
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K191777. 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 ES, Revolution Apex, Revolution CT with Apex edition?

Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K191777.

When did Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition receive FDA 510(k) clearance?

Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition received FDA 510(k) clearance on 2019-07-26, under 510(k) number K191777.

Who is the listed applicant for Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition?

The FDA 510(k) record lists Ge Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition?

The FDA product code for Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition 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.

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