510(k) K182223

Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A by Canon Medical Systems, USA — Product Code JAK

K182223 is an FDA 510(k) premarket notification submitted by Canon Medical Systems, USA for the device "Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A". The FDA issued a decision of Substantially Equivalent on Sep 14, 2018. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750.