# NQQ: System, Imaging, Optical Coherence Tomography (Oct)

- Device class: 2; regulation: 21 CFR 892.1560; FDA's rule: 510(k) required
- FDA decisions: 46
- 510(k) review time 2021–2025: median 112 days (middle half 81–185)
- Recalls: 2 (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: 5
- 2017: 1
- 2018: 2
- 2019: 3
- 2020: 2
- 2021: 2
- 2023: 3
- 2024: 2
- 2025: 8
- 2026: 1

## Most-cited predicates
- K033783: Imalux Oct Imaging System (2004), cited by 5
- K093520: Vivosight Topical Oct System (2010), cited by 4
- K112770: Nvision Vle Imaging System, Nvision Vle Catheter (2011), cited by 3
- K221257: SpectraWAVE Imaging System (2023), cited by 3
- K152120: OPTIS Mobile System (2015), cited by 3
- K093857: C7 XR Imaging System with C7 Dragonfly Imaging Catheter and Disposable Accessories (2010), cited by 2
- K123369: Ilumien Optis (2013), cited by 2
- K143678: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory (2015), cited by 2
- K210458: OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System (2021), cited by 2
- K042894: Imalux Niris Imaging System (2004), cited by 2

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