510(k) K132816

ONCENTRA BRACHY by Nucletron B.V. — Product Code MUJ

K132816 is an FDA 510(k) premarket notification submitted by Nucletron B.V. for the device "ONCENTRA BRACHY". The FDA issued a decision of Substantially Equivalent on June 13, 2014. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Nucletron B.V. has at least 10 other 510(k) clearances on record.