The following data is part of a premarket notification filed by Theratronics, Inc. with the FDA for Theratron Elite.
| Device ID | K983917 |
| 510k Number | K983917 |
| Device Name: | THERATRON ELITE |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | THERATRONICS, INC. 413 MARCH ROAD P.O. BOX 13140 Kanata Ontario, CA K2k 2b7 |
| Contact | E.s. Martell |
| Correspondent | E.s. Martell 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-04 |
| Decision Date | 1998-12-04 |
| Summary: | summary |