IWL
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- System, Radiation Therapy, Neutron, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.5300
- Medical specialty
- Radiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NEUTRON THERAPY SYSTEM (K063691) | Northern Illinois Univ. Outreach | 2007-01-31 |
| MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS (K852804) | Medcyc. Corp. | 1985-10-15 |
| ISOCENTRIC NEUTRON THERAPY SYSTEMS (K812337) | The Cyclotron Corp. | 1981-10-02 |
| MODEL 4100 14 MEV NEUTRON GEN. THERAPY (K811778) | The Cyclotron Corp. | 1981-07-23 |
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Every clearance here is in the API, with alerts when new ones post.