# LHN: System, Radiation Therapy, Charged-Particle, Medical

- Device class: 2; regulation: 21 CFR 892.5050; FDA's rule: 510(k) required
- FDA decisions: 93
- 510(k) review time 2021–2025: median 190 days (middle half 165–259)
- Recalls: 19 (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)
- 2016: 7
- 2017: 4
- 2018: 3
- 2019: 2
- 2020: 4
- 2022: 2
- 2023: 2
- 2024: 1
- 2025: 3
- 2026: 4

## Most-cited predicates
- K983024: Proton Therapy System (2001), cited by 8
- K983629: RPM Respiratory Gating System (1999), cited by 7
- K151132: Probeat-V (2015), cited by 6
- K053280: Probeat (2006), cited by 4
- K052118: Dose Verification System (2006), cited by 4
- K152592: Probeat-V (2015), cited by 4
- K102373: Calypso System with Dynamic Edge Gating (2010), cited by 3
- K983660: Exactrac (Brainlab Patient Positioning System) (1999), cited by 3
- K060695: Iba Proton Therapy System - Proteus 235 (2006), cited by 3
- K061152: Mucheck V7.0 (2006), cited by 3

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