# SHW: Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis

- Device class: 2; regulation: 21 CFR 864.3755; FDA's rule: 510(k) 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)
- 2026: 2

## Most-cited predicates
- K254115: ArteraAI Breast (2026), cited by 1

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