510(k) K071506

ECHELON SPECTROSCOPY PACKAGE by Hitachi Medical Systems America, Inc. — Product Code LNI

K071506 is an FDA 510(k) premarket notification submitted by Hitachi Medical Systems America, Inc. for the device "ECHELON SPECTROSCOPY PACKAGE". The FDA issued a decision of Substantially Equivalent on June 28, 2007. The device falls under product code LNI (System, Nuclear Magnetic Resonance Spectroscopic), a Class II device regulated under 21 CFR 892.1000. Hitachi Medical Systems America, Inc. has at least 10 other 510(k) clearances on record.