510(k) K130743

THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL by Ortho Kinematics, Inc. — Product Code LLZ

K130743 is an FDA 510(k) premarket notification submitted by Ortho Kinematics, Inc. for the device "THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL". The FDA issued a decision of Substantially Equivalent on August 6, 2013. 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.