Cleared Special

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

K191777 · Ge Medical Systems, LLC · Radiology

Jul 2019

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K191777 is an FDA 510(k) clearance for the Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on July 26, 2019, 24 days after receiving the submission on July 2, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number	K191777 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 02, 2019
Decision Date	July 26, 2019
Days to Decision	24 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF