# MOU: Intravascular Radiation Delivery System

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 3
- 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)
- 2002: 21
- 2003: 22
- 2004: 7
- 2006: 1
- 2008: 1
- 2011: 2
- 2016: 2
- 2017: 1
- 2019: 1
- 2024: 1

## Most-cited predicates

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