510(k) K213504

Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A by Canon Medical Systems Corporation — Product Code JAK

K213504 is an FDA 510(k) premarket notification submitted by Canon Medical Systems Corporation for the device "Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A". The FDA issued a decision of Substantially Equivalent on Jun 16, 2022. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Canon Medical Systems Corporation has 96 other 510(k) clearances on record.