510(k) K980306

GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP by Elscint, Inc. — Product Code LNH

K980306 is an FDA 510(k) premarket notification submitted by Elscint, Inc. for the device "GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP". The FDA issued a decision of Substantially Equivalent on April 2, 1998. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Elscint, Inc. has at least 10 other 510(k) clearances on record.