IWI
6 FDA 510(k) clearances · Product code
214 daysmedian time to decision
304 days90th percentile
6clearances measured
FDA profile
- Official device name
- Source, Isotope, Sealed, Gold, Titanium, Platinum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.5730
- Medical specialty
- Radiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1992: 1 · 1997: 2 · 1998: 1 · 2000: 1
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 |
|---|---|---|
| NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633 (K973363) | Ml Strategies, Inc. | 1998-07-02 |
| I-125 RAPID STRAND (K940632) | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1994-09-02 |
| RADIOACTIVE IODINE-125 SOURCES (K912170) | Best Industries | 1991-08-09 |
| CESIUM 137 SOURCE, MODEL CSM-40 (K882449) | Cis-Us, Inc. | 1989-04-14 |
| MODIFIED PALLADIUM SEED MODEL 100 (K874787) | Theragenics Corp. | 1987-12-22 |
| PALLADIUM SEED MODEL 100 (K852542) | Nuclear Medicine, Inc. | 1986-01-14 |
Track IWI automatically
Every clearance here is in the API, with alerts when new ones post.