510(k) K161748

SUPRIA w/guideShot Option by Hitachi Medical Systems America, Inc. — Product Code JAK

K161748 is an FDA 510(k) premarket notification submitted by Hitachi Medical Systems America, Inc. for the device "SUPRIA w/guideShot Option". The FDA issued a decision of Substantially Equivalent on August 17, 2016. 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.