510(k) K080929

ONCENTRA GYN by Nucletron Corporation — Product Code MUJ

K080929 is an FDA 510(k) premarket notification submitted by Nucletron Corporation for the device "ONCENTRA GYN". The FDA issued a decision of Substantially Equivalent on April 16, 2008. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Nucletron Corporation has at least 10 other 510(k) clearances on record.