The following data is part of a premarket notification filed by Atomic Energy Of Canada with the FDA for Theratron 780c A Radionuclide Radiation Therapy Sy.
| Device ID | K850543 |
| 510k Number | K850543 |
| Device Name: | THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | ATOMIC ENERGY OF CANADA 413 MARCH ROAD P.O. BOX 13140 Kanata, Ontario, CA K2k 2b7 |
| Contact | Slobodian |
| Correspondent | Slobodian ATOMIC ENERGY OF CANADA 413 MARCH ROAD P.O. BOX 13140 Kanata, Ontario, CA K2k 2b7 |
| Product Code | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-11 |
| Decision Date | 1985-05-10 |