510(k) K972592

2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) by Elscint, Inc. — Product Code MOS

K972592 is an FDA 510(k) premarket notification submitted by Elscint, Inc. for the device "2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)". The FDA issued a decision of Substantially Equivalent on September 15, 1997. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Elscint, Inc. has at least 10 other 510(k) clearances on record.