510(k) K020164

E-SCAN XQ by Biosound Esaote, Inc. — Product Code LNH

K020164 is an FDA 510(k) premarket notification submitted by Biosound Esaote, Inc. for the device "E-SCAN XQ". The FDA issued a decision of Substantially Equivalent on February 12, 2002. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Biosound Esaote, Inc. has at least 10 other 510(k) clearances on record.