510(k) K003366

MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL by Igc-Medical Advances, Inc. — Product Code MOS

K003366 is an FDA 510(k) premarket notification submitted by Igc-Medical Advances, Inc. for the device "MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL". The FDA issued a decision of Substantially Equivalent on Dec 22, 2000. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Igc-Medical Advances, Inc. has 6 other 510(k) clearances on record.