510(k) K181498

X-ray Imaging System for the McLaren Proton Treatment System by Ehmetdx, LLC — Product Code LHN

K181498 is an FDA 510(k) premarket notification submitted by Ehmetdx, LLC for the device "X-ray Imaging System for the McLaren Proton Treatment System". The FDA issued a decision of Substantially Equivalent on December 10, 2018. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050.