# KPQ: System, Simulation, Radiation Therapy

- Device class: 2; regulation: 21 CFR 892.5840; FDA's rule: 510(k) required
- FDA decisions: 70
- Recalls: 13 (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)
- 2003: 2
- 2004: 1
- 2005: 2
- 2006: 1
- 2007: 1
- 2008: 1
- 2009: 1
- 2010: 1
- 2013: 1
- 2014: 1

## Most-cited predicates
- K923851: Acqsim Simulator/Localizer (1992), cited by 7
- K951830: Advantage Sim (1995), cited by 4
- K061006: Ikoengelo (2006), cited by 4
- K021780: Advantage Sim 6.0 (2002), cited by 3
- K896353: GE Target Series 2 (1989), cited by 3
- K083591: Ikoengelo, Version 2 (2008), cited by 3
- K946128: Simulix-HP (1995), cited by 2
- K052345: Advantage Sim MD (2005), cited by 2
- K013531: Qwiksim Virtual Simulation System; Version 2.00 (2001), cited by 2
- K992751: Somavision (2000), cited by 2

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