The following data is part of a premarket notification filed by International Isotopes, Inc. with the FDA for I3rad 125 I Brachytherapy Seed, Model I125-0401.
| Device ID | K992963 |
| 510k Number | K992963 |
| Device Name: | I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | INTERNATIONAL ISOTOPES, INC. 3100 JIM CHRISTAL RD. Denton, TX 76207 -2600 |
| Contact | Rebecca Ellis |
| Correspondent | Rebecca Ellis INTERNATIONAL ISOTOPES, INC. 3100 JIM CHRISTAL RD. Denton, TX 76207 -2600 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-02 |
| Decision Date | 1999-09-21 |
| Summary: | summary |