510(k) K060401

MEDRAD 3.0T ECOIL IMAGING SYSTEM by Medrad, Inc. — Product Code MOS

K060401 is an FDA 510(k) premarket notification submitted by Medrad, Inc. for the device "MEDRAD 3.0T ECOIL IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 15, 2006. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Medrad, Inc. has at least 10 other 510(k) clearances on record.