510(k) K213715

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

K213715 is an FDA 510(k) premarket notification submitted by Ge Medical Systems, LLC for the device "Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition". The FDA issued a decision of Substantially Equivalent on Dec 17, 2021. 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.