510(k) K132944

ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION by Ge Hungary Kft — Product Code KPQ

K132944 is an FDA 510(k) premarket notification submitted by Ge Hungary Kft for the device "ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION". The FDA issued a decision of Substantially Equivalent on March 14, 2014. The device falls under product code KPQ (System, Simulation, Radiation Therapy), a Class II device regulated under 21 CFR 892.5840. Ge Hungary Kft has at least 1 other 510(k) clearance on record.