510(k) K170858

FDR AQRO (DR-XD 1000) by Fujifilm Medical Systems U.S.A, Inc. — Product Code IZL

K170858 is an FDA 510(k) premarket notification submitted by Fujifilm Medical Systems U.S.A, Inc. for the device "FDR AQRO (DR-XD 1000)". The FDA issued a decision of Substantially Equivalent on April 24, 2017. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Fujifilm Medical Systems U.S.A, Inc. has at least 10 other 510(k) clearances on record.