510(k) K994117

MR ENHANCER by I.Z.I. Corp. — Product Code LNH

K994117 is an FDA 510(k) premarket notification submitted by I.Z.I. Corp. for the device "MR ENHANCER". The FDA issued a decision of Substantially Equivalent on February 4, 2000. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. I.Z.I. Corp. has at least 6 other 510(k) clearances on record.