510(k) K160405

OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D by Ptw-Freiburg Physikalisch-Technische-Werkstaetten — Product Code IYE

K160405 is an FDA 510(k) premarket notification submitted by Ptw-Freiburg Physikalisch-Technische-Werkstaetten for the device "OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D". The FDA issued a decision of Substantially Equivalent on Oct 20, 2017. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Ptw-Freiburg Physikalisch-Technische-Werkstaetten has 2 other 510(k) clearances on record.