510(k) K162177

dS FootAnkle I6CH 1.5T Coil by Invivo Corporation — Product Code MOS

K162177 is an FDA 510(k) premarket notification submitted by Invivo Corporation for the device "dS FootAnkle I6CH 1.5T Coil". The FDA issued a decision of Substantially Equivalent on September 14, 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.