Product code IWG
- Device name
- Seed, Isotope, Gold, Titanium, Platinum
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.5730
- Review panel
- RA
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K081066 | BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 | Medi-Physics, Inc., Dba GE Healthcare | 2008-05-05 |
| K982421 | IMAGYN 125 I SEED, MODEL IS 125 | International Isotopes, Inc. | 1998-07-31 |
| K834027 | GOLD SEADS | Radiation Safety & Nuclear Products, Inc. | 1983-12-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840682100991 | I-125 SeedTM Sterile Convenience Pack | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682101974 | I-125 SeedTM Sterile Convenience Pack | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682101929 | I-125 SeedTM Sterile Convenience Pack | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682101868 | Thin SeedTM | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682101820 | Thin SeedTM | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682101721 | Thin SeedTM | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682101653 | Thin SeedTM | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682101622 | Thin SeedTM | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682101592 | Thin SeedTM | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682101349 | Thin SeedTM | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682101271 | Thin SeedTM | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682101264 | I-125 SeedTM Sterile Convenience Pack | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682101196 | I-125 SeedTM Sterile Convenience Pack | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682101189 | I-125 SeedTM Sterile Convenience Pack | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682101127 | Thin SeedTM | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682100427 | I-125 SeedTM Sterile Convenience Pack | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682100977 | Thin SeedTM | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682100960 | I-125 SeedTM Sterile Convenience Pack | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682100953 | Thin SeedTM | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682100922 | Thin SeedTM | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682100915 | Thin SeedTM | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682100861 | I-125 SeedTM Sterile Convenience Pack | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682100823 | I-125 SeedTM Sterile Convenience Pack | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682100779 | Thin SeedTM | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682100748 | Thin SeedTM | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682100595 | Thin SeedTM | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682100588 | Thin SeedTM | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682100564 | Thin SeedTM | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682100465 | Thin SeedTM | MEDI-PHYSICS, INC. | 2015-09-24 |
| 00840682100434 | I-125 SeedTM Sterile Convenience Pack | MEDI-PHYSICS, INC. | 2015-09-24 |