# PCS: Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

- Device class: 2; regulation: 21 CFR 892.1001; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 27 days (middle half 27–27)
- 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)
- 2013: 1
- 2018: 1
- 2021: 1

## Most-cited predicates
- K182218: FerriSmart Analysis System (2018), cited by 1
- DEN130012: Ferriscan R2-Mri Analysis System (2013), cited by 1

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