510(k) K123327

1.5T GEM RT OPEN ARRAY by Ge Healthcare Coils (Usa Instruments, Inc.) — Product Code MOS

K123327 is an FDA 510(k) premarket notification submitted by Ge Healthcare Coils (Usa Instruments, Inc.) for the device "1.5T GEM RT OPEN ARRAY". The FDA issued a decision of Substantially Equivalent on January 11, 2013. 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.