ISOCENTRIC NEUTRON THERAPY SYSTEMS
Device Facts
| Record ID | K812337 |
|---|---|
| Device Name | ISOCENTRIC NEUTRON THERAPY SYSTEMS |
| Applicant | The Cyclotron Corp. |
| Product Code | IWL · Radiology |
| Decision Date | Oct 2, 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.
