510(k) K112109

THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE by Ortho Kinematics, Inc. — Product Code LLZ

K112109 is an FDA 510(k) premarket notification submitted by Ortho Kinematics, Inc. for the device "THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE". The FDA issued a decision of Substantially Equivalent on December 22, 2011. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Ortho Kinematics, Inc. has at least 5 other 510(k) clearances on record.