# JAK: System, X-Ray, Tomography, Computed

- Device class: 2; regulation: 21 CFR 892.1750; FDA's rule: 510(k) required
- FDA decisions: 827
- 510(k) review time 2021–2025: median 140 days (middle half 106–205)
- Recalls: 460 (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)
- 2017: 29
- 2018: 24
- 2019: 28
- 2020: 30
- 2021: 20
- 2022: 30
- 2023: 27
- 2024: 26
- 2025: 27
- 2026: 21

## Most-cited predicates
- K041521: Volume Viewer Plus (2004), cited by 17
- K083227: Vida Pulmonary Workstation 2 (PW2) (2008), cited by 12
- K012009: MX8000 Idt CT System (2001), cited by 11
- K033326: Philips Plus Computed Tomography System (2003), cited by 9
- K060937: Brilliance Volume (2006), cited by 8
- K041267: Cardiq Analysis Iii (2004), cited by 7
- K053610: Abaris (2006), cited by 7
- K083524: Syngo Dual Energy with Extended Funationally (2009), cited by 7
- K060903: IG4 Image Guided System (2006), cited by 7
- K052839: CT Perfusion 4 (2006), cited by 7

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