510(k) K182590

1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA by GE Healthcare — Product Code MOS

K182590 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA". The FDA issued a decision of Substantially Equivalent on Oct 19, 2018. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. GE Healthcare has 168 other 510(k) clearances on record.