510(k) K111802

SV BRAIN ARRAY, SIEMENS 3T by Mri Interventions, Inc. — Product Code MOS

K111802 is an FDA 510(k) premarket notification submitted by Mri Interventions, Inc. for the device "SV BRAIN ARRAY, SIEMENS 3T". The FDA issued a decision of Substantially Equivalent on September 8, 2011. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Mri Interventions, Inc. has at least 10 other 510(k) clearances on record.