510(k) K003144

MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL by Medical Advances, Inc. — Product Code MOS

K003144 is an FDA 510(k) premarket notification submitted by Medical Advances, Inc. for the device "MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL". The FDA issued a decision of Substantially Equivalent on Dec 13, 2000. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Medical Advances, Inc. has 56 other 510(k) clearances on record.