510(k) K113732

IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) by Brainlab AG — Product Code JAK

K113732 is an FDA 510(k) premarket notification submitted by Brainlab AG for the device "IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)". The FDA issued a decision of Substantially Equivalent on May 7, 2012. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Brainlab AG has at least 10 other 510(k) clearances on record.