510(k) K191777

Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition by Ge Medical Systems, LLC — Product Code JAK

K191777 is an FDA 510(k) premarket notification submitted by Ge Medical Systems, LLC for the device "Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition". The FDA issued a decision of Substantially Equivalent on Jul 26, 2019. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Ge Medical Systems, LLC has 328 other 510(k) clearances on record.