IWD · Device, Beam Limiting, Teletherapy, Radionuclide
Radiology · 21 CFR 892.5750 · Class 2
Overview
| Product Code | IWD |
|---|---|
| Device Name | Device, Beam Limiting, Teletherapy, Radionuclide |
| Regulation | 21 CFR 892.5750 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K964607 | THERATON 1000E | Theratronics, Inc. | May 28, 1997 | SESE |
Top Applicants
- Theratronics, Inc. — 1 clearance
