# IYE: Accelerator, Linear, Medical

- Device class: 2; regulation: 21 CFR 892.5050; FDA's rule: 510(k) required
- FDA decisions: 738
- 510(k) review time 2021–2025: median 136 days (middle half 64–227)
- Recalls: 380 (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)
- 2017: 23
- 2018: 21
- 2019: 19
- 2020: 20
- 2021: 19
- 2022: 12
- 2023: 18
- 2024: 9
- 2025: 12
- 2026: 14

## Most-cited predicates
- K071614: Fiducial Markers (2007), cited by 11
- K060906: Calypso 4D Localization System (2006), cited by 8
- K940663: Peacock Plan (1996), cited by 7
- K060226: Oncor Expression (2006), cited by 7
- K140660: MOBIUS3D (2014), cited by 7
- K072485: Artiste MV SA (2007), cited by 6
- K892425: STP Complete Module Set (1990), cited by 6
- K934523: Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth Confirmation Helmet (DH-1) (1995), cited by 6
- K003636: Portalvision (2001), cited by 6
- K003285: Exac Trac 2.0 (Novalis Body Module) (2001), cited by 6

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