MODEL 4100 14 MEV NEUTRON GEN. THERAPY
Device Facts
| Record ID | K811778 |
|---|---|
| Device Name | MODEL 4100 14 MEV NEUTRON GEN. THERAPY |
| Applicant | The Cyclotron Corp. |
| Product Code | IWL · Radiology |
| Decision Date | Jul 23, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.5300 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A medical neutron radiation therapy system is a device intended to generate high-energy neutrons for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment support, treatment planning computer programs, component parts, and accessories.
