510(k) K082964

PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5) by Prism Clinical Imaging, Inc. — Product Code LNH

K082964 is an FDA 510(k) premarket notification submitted by Prism Clinical Imaging, Inc. for the device "PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5)". The FDA issued a decision of Substantially Equivalent on March 9, 2009. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Prism Clinical Imaging, Inc. has at least 1 other 510(k) clearance on record.