510(k) K122109

AQUILION ONE VISION, V4.90 by Toshiba America Medical Systems, In.C — Product Code JAK

K122109 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "AQUILION ONE VISION, V4.90". The FDA issued a decision of Substantially Equivalent on September 21, 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.