# MVC: System, Test, Her-2/Neu, Ihc

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 4
- Recalls: 7 (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: 5
- 2018: 2
- 2019: 7
- 2020: 6
- 2021: 1
- 2022: 3
- 2023: 2
- 2024: 3
- 2025: 4
- 2026: 5

## Most-cited predicates
- P980018: Dako Herceptest (1998), cited by 1

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