510(k) K122694

GE 8CH FOOT ANKLE COIL by Ge Hangwei Medical Systems Co., Ltd. — Product Code MOS

K122694 is an FDA 510(k) premarket notification submitted by Ge Hangwei Medical Systems Co., Ltd. for the device "GE 8CH FOOT ANKLE COIL". The FDA issued a decision of Substantially Equivalent on October 25, 2012. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), 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.