# LLZ: System, Image Processing, Radiological

- Device class: 2; regulation: 21 CFR 892.2050; FDA's rule: 510(k) required
- FDA decisions: 2,295
- 510(k) review time 2021–2025: median 143 days (middle half 73–229)
- Recalls: 341 (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: 78
- 2018: 104
- 2019: 74
- 2020: 81
- 2021: 83
- 2022: 65
- 2023: 87
- 2024: 62
- 2025: 58
- 2026: 45

## Most-cited predicates
- K033849: Simplant System (2004), cited by 20
- K183105: Mimics Medical (2019), cited by 17
- K013922: Coronis 3MP Medicl Flat Panel Display System (2002), cited by 17
- K992654: Plug 'N View 3D, Version 1.0 (1999), cited by 16
- K071331: Vitrea Version 4.0 (2007), cited by 15
- K020995: Efilm Workstation with Modules (2002), cited by 15
- K021966: Q Lab Software (2002), cited by 14
- K170981: NeuroQuant (2017), cited by 14
- K010938: Syngo Multimodality Workstation (2001), cited by 13
- K002519: Vitrea 2, Version 2.1 (2000), cited by 13

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