# NSI: System, Imaging, Esophageal, Wireless, Capsule

- Device class: 2; regulation: 21 CFR 876.1300; FDA's rule: 510(k) required
- FDA decisions: 7
- 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
- 2005: 1
- 2006: 1
- 2007: 1
- 2009: 1
- 2018: 1

## Most-cited predicates
- K041149: Given Diagnostic System with M2A Eso Capsule (2004), cited by 5
- K042960: Given Diagnostic System with Pillcam Eso (2004), cited by 4
- K060805: Modification to Given Diagnostic System (2006), cited by 4
- K090557: Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile Patency System (2009), cited by 4
- K052184: Given Diagnostic System (2005), cited by 4
- K071153: Given Diagnostic System with Pillcam ESO2 Capsule (2007), cited by 2

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