510(k) K170019

Aquilion Lightning, TSX-036A/1, V8.4 by Toshibamedical Systems Corporation — Product Code JAK

K170019 is an FDA 510(k) premarket notification submitted by Toshibamedical Systems Corporation for the device "Aquilion Lightning, TSX-036A/1, V8.4". The FDA issued a decision of Substantially Equivalent on Feb 2, 2017. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Toshibamedical Systems Corporation has 79 other 510(k) clearances on record.