510(k) K103330

BRIVO MR355, OPTIMA MR360 by Ge Hangwei Medical Systems Co., Ltd. — Product Code LNH

K103330 is an FDA 510(k) premarket notification submitted by Ge Hangwei Medical Systems Co., Ltd. for the device "BRIVO MR355, OPTIMA MR360". The FDA issued a decision of Substantially Equivalent on February 11, 2011. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Ge Hangwei Medical Systems Co., Ltd. has at least 9 other 510(k) clearances on record.