510(k) K113102

ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING by Nucletron — Product Code MUJ

K113102 is an FDA 510(k) premarket notification submitted by Nucletron for the device "ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING". The FDA issued a decision of Substantially Equivalent on December 12, 2011. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Nucletron has at least 10 other 510(k) clearances on record.