510(k) K170490

Celesteion, PCA-9000A/3 by Toshibamedical Systems Corporation — Product Code KPS

K170490 is an FDA 510(k) premarket notification submitted by Toshibamedical Systems Corporation for the device "Celesteion, PCA-9000A/3". The FDA issued a decision of Substantially Equivalent on Jun 1, 2017. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Toshibamedical Systems Corporation has 79 other 510(k) clearances on record.