510(k) K000589

MODEL 445SI-64E QUADRATURE WRIST COIL by Igc-Medical Advances, Inc. — Product Code MOS

K000589 is an FDA 510(k) premarket notification submitted by Igc-Medical Advances, Inc. for the device "MODEL 445SI-64E QUADRATURE WRIST COIL". The FDA issued a decision of Substantially Equivalent on Mar 14, 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.