510(k) K162001

1.5T and 3.0T 16 CH GE Shoulder Coils by Invivo Corporation — Product Code MOS

K162001 is an FDA 510(k) premarket notification submitted by Invivo Corporation for the device "1.5T and 3.0T 16 CH GE Shoulder Coils". The FDA issued a decision of Substantially Equivalent on August 31, 2016. 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.