510(k) K011246

DCM 1.0 by Mds Nordion — Product Code MUJ

K011246 is an FDA 510(k) premarket notification submitted by Mds Nordion for the device "DCM 1.0". The FDA issued a decision of Substantially Equivalent on May 23, 2001. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Mds Nordion has at least 8 other 510(k) clearances on record.