510(k) K101492

8 CHANNEL CARDIAC PHASED ARRAY COIL by Ge Healthcare Coils (Usa Instruments, Inc.) — Product Code MOS

K101492 is an FDA 510(k) premarket notification submitted by Ge Healthcare Coils (Usa Instruments, Inc.) for the device "8 CHANNEL CARDIAC PHASED ARRAY COIL". The FDA issued a decision of Substantially Equivalent on June 23, 2010. 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.