510(k) K111340

HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM by Medtec, Inc. — Product Code LNH

K111340 is an FDA 510(k) premarket notification submitted by Medtec, Inc. for the device "HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 28, 2011. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Medtec, Inc. has at least 10 other 510(k) clearances on record.