510(k) K103506

1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300) by Imris, Inc. — Product Code MOS

K103506 is an FDA 510(k) premarket notification submitted by Imris, Inc. for the device "1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)". The FDA issued a decision of Substantially Equivalent on Feb 2, 2011. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Imris, Inc. has at least 10 other 510(k) clearances on record.