510(k) K181646

Celesteion, PCA-9000A/3, V6.5 by Canon Medical Systems Corporation — Product Code JAK

K181646 is an FDA 510(k) premarket notification submitted by Canon Medical Systems Corporation for the device "Celesteion, PCA-9000A/3, V6.5". The FDA issued a decision of Substantially Equivalent on Nov 16, 2018. 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.