510(k) K062386

QANGIO CT by Medis Medical Imaging Systems BV — Product Code JAK

K062386 is an FDA 510(k) premarket notification submitted by Medis Medical Imaging Systems BV for the device "QANGIO CT". The FDA issued a decision of Substantially Equivalent on October 5, 2006. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Medis Medical Imaging Systems BV has at least 10 other 510(k) clearances on record.