510(k) K071378

MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES by E-Z-Em, Inc. — Product Code JAK

K071378 is an FDA 510(k) premarket notification submitted by E-Z-Em, Inc. for the device "MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES". The FDA issued a decision of Substantially Equivalent on June 13, 2007. 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.