The following data is part of a premarket notification filed by Mds Nordion with the FDA for Theratron 780c/1000 With Computerized Console Upgrade.
| Device ID | K001006 |
| 510k Number | K001006 |
| Device Name: | THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | MDS NORDION 447 MARCH RD. Ottawa, Ontario, CA K2k1x8 |
| Contact | E S Martell |
| Correspondent | E S Martell MDS NORDION 447 MARCH RD. Ottawa, Ontario, CA K2k1x8 |
| Product Code | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-29 |
| Decision Date | 2000-04-27 |