IWB
- Product code
- IWB
- Device name
- System, Radiation Therapy, Radionuclide
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.5750
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 48 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250391 | 2025-07-02 | Elekta Solutions AB | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma … | |
| K232854 | 2024-02-08 | Elekta Solutions AB | Leksell GammaPlan (LGP) |
Official FDA classification page: IWB
Classification and pathway per current FDA publications. Data from openFDA (CC0).