The following data is part of a premarket notification filed by Atomic Energy Of Canada with the FDA for Linear Accelerator Therac 25.
| Device ID | K837347 |
| 510k Number | K837347 |
| Device Name: | LINEAR ACCELERATOR THERAC 25 |
| Classification | Accelerator, Linear, Medical |
| Applicant | ATOMIC ENERGY OF CANADA 413 MARCH ROAD P.O. BOX 13140 Kanata, Ontario, CA K2k 2b7 |
| Contact | Theratronics Intl |
| Correspondent | Theratronics Intl ATOMIC ENERGY OF CANADA 413 MARCH ROAD P.O. BOX 13140 Kanata, Ontario, CA K2k 2b7 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-04 |
| Decision Date | 1983-06-24 |