# DXK: Echocardiograph

- Device class: 2; regulation: 21 CFR 870.2330; FDA's rule: 510(k) required
- FDA decisions: 78
- 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)
- 1987: 6
- 1988: 7
- 1989: 3
- 1990: 12
- 1991: 7
- 1992: 1
- 1994: 1
- 2003: 1
- 2016: 1
- 2018: 1

## Most-cited predicates
- K031148: IN-Vision Imaging System (2003), cited by 6
- K894632: Model SSH-140A Ultrasound Imaging System (1989), cited by 1
- K851426: Accucom Cardiac Output Monitor (1985), cited by 1

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