510(k) K012728

E-SCAN MRI SYSTEM by Biosound Esaote, Inc. — Product Code MOS

K012728 is an FDA 510(k) premarket notification submitted by Biosound Esaote, Inc. for the device "E-SCAN MRI SYSTEM". The FDA issued a decision of Substantially Equivalent on August 29, 2001. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Biosound Esaote, Inc. has at least 10 other 510(k) clearances on record.