IWD — Device, Beam Limiting, Teletherapy, Radionuclide Class II
FDA product code IWD covers "Device, Beam Limiting, Teletherapy, Radionuclide", a Class II medical device regulated under 21 CFR 892.5750. Submissions are reviewed by the Radiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- IWD
- Device Class
- Class II
- Regulation Number
- 892.5750
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K964607 | theratronics | THERATON 1000E | May 28, 1997 |