Device, Beam Limiting, Teletherapy, Radionuclide
A radionuclide teletherapy beam limiting device is an accessory used with teletherapy units to shape and define the radiation field delivered from a radionuclide source, improving the precision and conformity of radiation therapy treatment. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IWD, regulated under 21 CFR 892.5750, within the Radiology medical specialty. This device is eligible for third party 510(k) review.
Research product code IWD in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- IWD
- Device Class
- FDA class 2
- Regulation Number
- 892.5750
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K964607 | THERATON 1000E | May 28, 1997 | Substantially Equivalent | Theratronics, Inc. |