510(k) K122897

SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 by Invivo Corporation — Product Code MOS

K122897 is an FDA 510(k) premarket notification submitted by Invivo Corporation for the device "SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645". The FDA issued a decision of Substantially Equivalent on December 21, 2012. 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.