# NWE: Colon Computed Tomography System, Computer Aided Detection

- Device class: 2; regulation: 21 CFR 892.2050; FDA's rule: 510(k) required
- FDA decisions: 4
- Recalls: 0 (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)
- 2004: 2
- 2011: 1
- 2014: 1

## Most-cited predicates
- K042605: Colongraphy Software Package with Extended Functionality (2004), cited by 4
- K042674: Colon Car 1.2 (2004), cited by 3
- K083423: Coloncad Api 3.1 (2011), cited by 1

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