510(k) K123509

SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM by Hitachi Medical Systems America, Inc. — Product Code JAK

K123509 is an FDA 510(k) premarket notification submitted by Hitachi Medical Systems America, Inc. for the device "SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM". The FDA issued a decision of Substantially Equivalent on March 29, 2013. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Hitachi Medical Systems America, Inc. has at least 10 other 510(k) clearances on record.