Product code IWD— Radiology
THERATON 1000E
- Classification name
- Device, Beam Limiting, Teletherapy, Radionuclide
- Device class
- Class 2
- Regulation
- 21 CFR 892.5750
- Advisory panel
- Radiology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code IWD
FDA has cleared device under product code IWD, all in 1997, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code IWD
Recent clearances under product code IWD
Data sourced from openFDA. This site is unofficial and independent of the FDA.