510(k) K033292

AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 by Igc-Medical Advances, Inc. — Product Code MOS

K033292 is an FDA 510(k) premarket notification submitted by Igc-Medical Advances, Inc. for the device "AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12". The FDA issued a decision of Substantially Equivalent on Nov 26, 2003. 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.