# NFJ: System, Image Management, Ophthalmic

- Device class: 2; regulation: 21 CFR 892.2050; FDA's rule: 510(k) required
- FDA decisions: 53
- 510(k) review time 2021–2025: median 214 days (middle half 91–235)
- Recalls: 7 (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
- 2017: 5
- 2018: 7
- 2019: 2
- 2020: 5
- 2021: 2
- 2022: 3
- 2023: 4
- 2024: 2
- 2026: 2

## Most-cited predicates
- K122938: Forum Forum Archive Forum Archive & Viewer Forum Assist Match (2012), cited by 11
- K013694: Nidek Advanced Vision Information System (Navis) (2002), cited by 7
- K082364: Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or Digital Imaging Software for (2008), cited by 6
- K090439: FORUM (2009), cited by 5
- K093313: Synergy (2009), cited by 4
- K173689: Ophthalmic Software Platform RX (2018), cited by 2
- K123464: Callisto Eye (2013), cited by 2
- K071299: IP System, Oculab IP, Optomize IP, Retasure IP (2007), cited by 2
- K170638: Retina Workplace (2017), cited by 2
- K151952: Synergy ODM (2015), cited by 2

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