510(k) K901639

MODEL 4050-64; 5.25 & 4065-64; 6.50 LOOP COIL by Medical Advances, Inc. — Product Code LNH

K901639 is an FDA 510(k) premarket notification submitted by Medical Advances, Inc. for the device "MODEL 4050-64; 5.25 & 4065-64; 6.50 LOOP COIL". The FDA issued a decision of Substantially Equivalent on May 14, 1990. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Medical Advances, Inc. has 56 other 510(k) clearances on record.