# IYX: Camera, Scintillation (Gamma)

- Device class: 1; regulation: 21 CFR 892.1100; FDA's rule: 510(k) required
- FDA decisions: 130
- 510(k) review time 2021–2025: median 385 days (middle half 299–470)
- Recalls: 6 (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)
- 2007: 2
- 2008: 2
- 2009: 2
- 2010: 4
- 2011: 3
- 2013: 1
- 2014: 1
- 2016: 2
- 2017: 1
- 2023: 2

## Most-cited predicates
- K163687: Olinda Exm (2017), cited by 5
- K961104: Notebook Imager (1997), cited by 4
- K885054: System Seventy Seven (1989), cited by 3
- K033960: Olinda/Exm (2004), cited by 3
- K993813: Lumagem Scintillation Camera (2000), cited by 3
- K904174: Starcam 4000 (1991), cited by 2
- K062141: Mammopad Radiolucent Cushion (2006), cited by 2
- K102231: Discovery NM 750B (2010), cited by 2
- K023373: Onepass Nuclear Imaging System, Model 70-500101 (2003), cited by 2
- K100838: Ergo Imaging System (2010), cited by 2

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