510(k) K112989

AQUILION CXL by Toshiba America Medical Systems, In.C — Product Code JAK

K112989 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "AQUILION CXL". The FDA issued a decision of Substantially Equivalent on April 10, 2012. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Toshiba America Medical Systems, In.C has at least 10 other 510(k) clearances on record.