The following data is part of a premarket notification filed by Mds Nordion Ab with the FDA for Dcm 2.0.
| Device ID | K020971 |
| 510k Number | K020971 |
| Device Name: | DCM 2.0 |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | MDS NORDION AB 447 MARCH ROAD Kanata, Ontario, CA K2k 1x8 |
| Contact | E. S Martell |
| Correspondent | E. S Martell MDS NORDION AB 447 MARCH ROAD Kanata, Ontario, CA K2k 1x8 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-26 |
| Decision Date | 2002-06-06 |
| Summary: | summary |