510(k) K180666

48CH Head Coil by Ge Healthcare Coils (Usa Instruments, Inc.) — Product Code MOS

K180666 is an FDA 510(k) premarket notification submitted by Ge Healthcare Coils (Usa Instruments, Inc.) for the device "48CH Head Coil". The FDA issued a decision of Substantially Equivalent on April 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.