510(k) K020971

DCM 2.0 by Mds Nordion AB — Product Code MUJ

K020971 is an FDA 510(k) premarket notification submitted by Mds Nordion AB for the device "DCM 2.0". The FDA issued a decision of Substantially Equivalent on June 6, 2002. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Mds Nordion AB has at least 8 other 510(k) clearances on record.