510(k) K223378

3.0T 16ch AIR AA by Ge Healthcare Coils (Usa Instruments, Inc.) — Product Code MOS

K223378 is an FDA 510(k) premarket notification submitted by Ge Healthcare Coils (Usa Instruments, Inc.) for the device "3.0T 16ch AIR AA". The FDA issued a decision of Substantially Equivalent on January 3, 2023. 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.