21 CFR 892.5300 — System, Radiation Therapy, Neutron, Medical
Radiology (RA) · Subpart F—Therapeutic Devices · § 892.5300
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IWL | System, Radiation Therapy, Neutron, Medical | 2 | 4 |
