510(k) K010057

MODIFICATION TO ARTOSCAN M by Biosound Esaote, Inc. — Product Code LNH

K010057 is an FDA 510(k) premarket notification submitted by Biosound Esaote, Inc. for the device "MODIFICATION TO ARTOSCAN M". The FDA issued a decision of Substantially Equivalent on February 2, 2001. 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.