510(k) K071611

NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL by Neocoil — Product Code MOS

K071611 is an FDA 510(k) premarket notification submitted by Neocoil for the device "NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL". The FDA issued a decision of Substantially Equivalent on June 28, 2007. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Neocoil has at least 10 other 510(k) clearances on record.