510(k) K121997

IMRIS ONCOLOGY PACKAGE by Imris, Inc. — Product Code LNH

K121997 is an FDA 510(k) premarket notification submitted by Imris, Inc. for the device "IMRIS ONCOLOGY PACKAGE". The FDA issued a decision of Substantially Equivalent on August 10, 2012. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Imris, Inc. has at least 10 other 510(k) clearances on record.