# IWB: System, Radiation Therapy, Radionuclide

- Device class: 2; regulation: 21 CFR 892.5750; FDA's rule: 510(k) required
- FDA decisions: 48
- 510(k) review time 2021–2025: median 135 days (middle half 128–140)
- Recalls: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2015: 3
- 2016: 1
- 2017: 1
- 2018: 3
- 2019: 1
- 2020: 1
- 2021: 2
- 2022: 1
- 2024: 1
- 2025: 1

## Most-cited predicates
- K973441: Leksell Gammaplan (1998), cited by 4
- K051022: Gammaplan (2005), cited by 2
- K200050: Akesis Galaxy RTx (2020), cited by 2
- K133565: Leksell Gamma Knife Perfexion (2014), cited by 2
- K863180: Theratron-Phoenix (1986), cited by 2
- K061540: Leksell Gammaplan (2006), cited by 2
- K914808: Leksell Gammaplan (LGP) (1992), cited by 2
- K970647: Our Rotating Gamma System (1997), cited by 2
- K061941: Leksell Gamma Knife Perfexion, Model 715000 (2006), cited by 2
- K912250: Isorad (TM) Integral Buildup Photon Diodes (1991), cited by 2

Source page: https://510kreport.com/product-code/IWB
Data by year (CSV): https://510kreport.com/product-code/IWB.csv