# NRZ: Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 2
- 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)
- 2009: 2
- 2010: 2
- 2011: 2
- 2012: 3
- 2013: 5
- 2014: 1
- 2015: 2
- 2016: 5
- 2018: 3
- 2025: 1

## Most-cited predicates

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