510(k) K111673

1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL by Invivo Corporation — Product Code MOS

K111673 is an FDA 510(k) premarket notification submitted by Invivo Corporation for the device "1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL". The FDA issued a decision of Substantially Equivalent on December 23, 2011. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Invivo Corporation has at least 10 other 510(k) clearances on record.