510(k) K161163

PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory by Hitachi , Ltd. — Product Code LHN

K161163 is an FDA 510(k) premarket notification submitted by Hitachi , Ltd. for the device "PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory". The FDA issued a decision of Substantially Equivalent on July 13, 2016. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050. Hitachi , Ltd. has at least 7 other 510(k) clearances on record.