510(k) K162079

TRILLIUM Oval Head Coil 32 by Hitachi Medical Systems America, Inc. — Product Code MOS

K162079 is an FDA 510(k) premarket notification submitted by Hitachi Medical Systems America, Inc. for the device "TRILLIUM Oval Head Coil 32". The FDA issued a decision of Substantially Equivalent on September 16, 2016. 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.