510(k) K954039

GYREX PRIVILEGE by Elscint, Inc. — Product Code LNH

K954039 is an FDA 510(k) premarket notification submitted by Elscint, Inc. for the device "GYREX PRIVILEGE". The FDA issued a decision of Substantially Equivalent on November 24, 1995. 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.