510(k) K163528

HITACHI Supria Whole-body X-ray CT System Phase 3 by Hitachi Medical Systems America, Inc. — Product Code JAK

K163528 is an FDA 510(k) premarket notification submitted by Hitachi Medical Systems America, Inc. for the device "HITACHI Supria Whole-body X-ray CT System Phase 3". The FDA issued a decision of Substantially Equivalent on March 3, 2017. 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.