FDA Product Code
FDA Product Code IWL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5300
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K063691 | NEUTRON THERAPY SYSTEM | Northern Illinois Univ. Outreach | 2007-01-31 | Traditional | PDF ↗ |
| K852804 | MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS | Medcyc. Corp. | 1985-10-15 | Traditional | PDF ↗ |
| K812337 | ISOCENTRIC NEUTRON THERAPY SYSTEMS | The Cyclotron Corp. | 1981-10-02 | Traditional | PDF ↗ |
| K811778 | MODEL 4100 14 MEV NEUTRON GEN. THERAPY | The Cyclotron Corp. | 1981-07-23 | Traditional | PDF ↗ |
Product code IWL · Class II · Radiology. Data: openFDA.