510(k) K093348

3.0T 16 CHANNEL HEAD NECK SPINE COIL by Ge Healthcare Coils (Usa Instruments, Inc.) — Product Code MOS

K093348 is an FDA 510(k) premarket notification submitted by Ge Healthcare Coils (Usa Instruments, Inc.) for the device "3.0T 16 CHANNEL HEAD NECK SPINE COIL". The FDA issued a decision of Substantially Equivalent on November 25, 2009. 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.