510(k) K122646

DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T by Invivo Corporation — Product Code MOS

K122646 is an FDA 510(k) premarket notification submitted by Invivo Corporation for the device "DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T". The FDA issued a decision of Substantially Equivalent on November 2, 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.