510(k) K102889

HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON by Hitachi Medical Systems America, Inc. — Product Code MOS

K102889 is an FDA 510(k) premarket notification submitted by Hitachi Medical Systems America, Inc. for the device "HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON". The FDA issued a decision of Substantially Equivalent on December 20, 2010. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Hitachi Medical Systems America, Inc. has at least 10 other 510(k) clearances on record.