510(k) K123681

1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL by Wipro GE Healthcare Private, Ltd. — Product Code MOS

K123681 is an FDA 510(k) premarket notification submitted by Wipro GE Healthcare Private, Ltd. for the device "1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL". The FDA issued a decision of Substantially Equivalent on February 22, 2013. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Wipro GE Healthcare Private, Ltd. has at least 4 other 510(k) clearances on record.