The following data is part of a premarket notification filed by Isoaid with the FDA for Isoaid Iodine Brachtherapy Seeds, Model Advantage I-125.
| Device ID | K011205 |
| 510k Number | K011205 |
| Device Name: | ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | ISOAID 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Contact | Art Ward |
| Correspondent | Art Ward ISOAID 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-19 |
| Decision Date | 2001-07-10 |