IWL · System, Radiation Therapy, Neutron, Medical
Radiology · 21 CFR 892.5300 · Class 2
Overview
| Product Code | IWL |
|---|---|
| Device Name | System, Radiation Therapy, Neutron, Medical |
| Regulation | 21 CFR 892.5300 |
| Device Class | Class 2 |
| Review Panel | Radiology |
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.
Classification Rationale
Class II.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K063691 | NEUTRON THERAPY SYSTEM | Northern Illinois Univ. Outreach | Jan 31, 2007 | SESE |
| K852804 | MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS | Medcyc. Corp. | Oct 15, 1985 | SESE |
| K812337 | ISOCENTRIC NEUTRON THERAPY SYSTEMS | The Cyclotron Corp. | Oct 2, 1981 | SESE |
| K811778 | MODEL 4100 14 MEV NEUTRON GEN. THERAPY | The Cyclotron Corp. | Jul 23, 1981 | SESE |
Top Applicants
- The Cyclotron Corp. — 2 clearances
- Medcyc. Corp. — 1 clearance
- Northern Illinois Univ. Outreach — 1 clearance
