The following data is part of a premarket notification filed by Theratronics, Inc. with the FDA for Theratron 1000.
| Device ID | K894165 |
| 510k Number | K894165 |
| Device Name: | THERATRON 1000 |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | THERATRONICS, INC. 413 MARCH ROAD P.O. BOX 13140 Kanata Ontario, CA K2k 2b7 |
| Contact | Strike |
| Correspondent | Strike THERATRONICS, INC. 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 | 1989-06-16 |
| Decision Date | 1990-02-01 |