510(k) K063029

EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 by E-Z-Em, Inc. — Product Code JAK

K063029 is an FDA 510(k) premarket notification submitted by E-Z-Em, Inc. for the device "EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900". The FDA issued a decision of Substantially Equivalent on November 2, 2006. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. E-Z-Em, Inc. has at least 10 other 510(k) clearances on record.