510(k) K171463

ASPIRE Bellus II by Fujifilm Medical Systems U.S.A, Inc. — Product Code LLZ

K171463 is an FDA 510(k) premarket notification submitted by Fujifilm Medical Systems U.S.A, Inc. for the device "ASPIRE Bellus II". The FDA issued a decision of Substantially Equivalent on September 29, 2017. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Fujifilm Medical Systems U.S.A, Inc. has at least 10 other 510(k) clearances on record.