21 CFR 892.5840 — System, Simulation, Radiation Therapy
Radiology (RA) · Subpart F—Therapeutic Devices · § 892.5840
Identification
A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KPQ | System, Simulation, Radiation Therapy | 2 | 70 | 3rd Party |
