510(k) K182504

3.0T Air MP M, 3.0T Air MP L by Ge Healthcare Coils (Usa Instruments, Inc.) — Product Code MOS

K182504 is an FDA 510(k) premarket notification submitted by Ge Healthcare Coils (Usa Instruments, Inc.) for the device "3.0T Air MP M, 3.0T Air MP L". The FDA issued a decision of Substantially Equivalent on October 12, 2018. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Ge Healthcare Coils (Usa Instruments, Inc.) has at least 10 other 510(k) clearances on record.