IWH · Source, Teletherapy, Radionuclide
Radiology · 21 CFR 892.5740 · Class 1
Overview
| Product Code | IWH |
|---|---|
| Device Name | Source, Teletherapy, Radionuclide |
| Regulation | 21 CFR 892.5740 |
| Device Class | Class 1 |
| Review Panel | Radiology |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
