510(k) K052345

ADVANTAGE SIM MD by GE Healthcare — Product Code KPQ

K052345 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "ADVANTAGE SIM MD". The FDA issued a decision of Substantially Equivalent on September 14, 2005. The device falls under product code KPQ (System, Simulation, Radiation Therapy), a Class II device regulated under 21 CFR 892.5840. GE Healthcare has at least 10 other 510(k) clearances on record.