# OIW: Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types

- Device class: 2; regulation: 21 CFR 862.3100; FDA's rule: 510(k) required
- FDA decisions: 4
- 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)
- 2008: 1
- 2010: 1
- 2012: 1
- 2018: 1

## Most-cited predicates
- K120489: Tissue of Origin Test Kit Ffpe (2012), cited by 1
- K092967: Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-Ffpe (2010), cited by 1
- K080896: Pathwork Diagnostics Tissue of Origin Test (2008), cited by 1

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