21 CFR 892.5750 — System, Radiation Therapy, Radionuclide
Radiology (RA) · Subpart F—Therapeutic Devices · § 892.5750
Identification
A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IWB | System, Radiation Therapy, Radionuclide | 2 | 48 | |
| IWD | Device, Beam Limiting, Teletherapy, Radionuclide | 2 | 1 | 3rd Party |
