21 CFR 892.5740 — Source, Teletherapy, Radionuclide
Radiology (RA) · Subpart F—Therapeutic Devices · § 892.5740
Identification
A radionuclide teletherapy source is a device consisting of a radionuclide enclosed in a sealed container. The device is intended for radiation therapy, with the radiation source located at a distance from the patient's body.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IWH | Source, Teletherapy, Radionuclide | 1 | 0 |
