IWG
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Seed, Isotope, Gold, Titanium, Platinum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.5730
- Medical specialty
- Radiology
- Flags
- Implant
- Adverse events (MAUDE)
- 1999: 2 · 2000: 1 · 2001: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 (K081066) | Medi-Physics, Inc., Dba GE Healthcare | 2008-05-05 |
| IMAGYN 125 I SEED, MODEL IS 125 (K982421) | International Isotopes, Inc. | 1998-07-31 |
| GOLD SEADS (K834027) | Radiation Safety & Nuclear Products, Inc. | 1983-12-27 |
Track IWG automatically
Every clearance here is in the API, with alerts when new ones post.