IWL — System, Radiation Therapy, Neutron, Medical Class II
FDA product code IWL covers "System, Radiation Therapy, Neutron, Medical", a Class II medical device regulated under 21 CFR 892.5300. Submissions are reviewed by the Radiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IWL
- Device Class
- Class II
- Regulation Number
- 892.5300
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K063691 | northern illinois univ. outreach | NEUTRON THERAPY SYSTEM | January 31, 2007 |
| K852804 | medcyc | MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS | October 15, 1985 |
| K812337 | cyclotron | ISOCENTRIC NEUTRON THERAPY SYSTEMS | October 2, 1981 |
| K811778 | cyclotron | MODEL 4100 14 MEV NEUTRON GEN. THERAPY | July 23, 1981 |