510(k) K113474

1.5T GEM FLEX COIL by Neocoil, LLC — Product Code MOS

K113474 is an FDA 510(k) premarket notification submitted by Neocoil, LLC for the device "1.5T GEM FLEX COIL". The FDA issued a decision of Substantially Equivalent on March 16, 2012. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Neocoil, LLC has at least 10 other 510(k) clearances on record.