510(k) K151207

Proton Immobilization Solution by Orfit Industries NV — Product Code IYE

K151207 is an FDA 510(k) premarket notification submitted by Orfit Industries NV for the device "Proton Immobilization Solution". The FDA issued a decision of Substantially Equivalent on July 28, 2015. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Orfit Industries NV has at least 10 other 510(k) clearances on record.