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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 a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2019-07-26 under approval 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. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K191777.

When was Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition approved by the FDA?

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

What company makes 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 manufactured by Ge Medical Systems, LLC.

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.

Other Devices by Ge Medical Systems, LLC

K163213Revolution CT K162403HyperBand K162990Optima XR240amx K161397MAGiC K161574Discovery MI K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T

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Related Devices (Code: JAK)

K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. K163213Revolution CTGe Medical Systems, LLC K161157Vitrea CT Dual Energy Image ViewVital Images, Inc. K160723OnSight 3D Extremity SystemCarestream Health, Inc. K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.

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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