# SimBioSys, Inc.

- Location (FDA's records): Chicago, IL
- FDA decisions: 4 (2023–2026): 4 510(k) clearances
- Product codes: QIH (3), SHW (1)
- 510(k) review time since 2016: median 29 days, against 150 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Confirma, Inc.: 1 (https://510kreport.com/company/confirma)
- Artera, Inc.: 1 (https://510kreport.com/company/artera)

## Its most-cited devices
- K243189: TumorSight Viz (2024), cited by 1
- K231130: TumorSight Viz (2023), cited by 1

## Recent decisions
- K260023: TumorSight Risk (Sep 25, 2026)
- K251766: TumorSight Viz (Jul 8, 2025)
- K243189: TumorSight Viz (Oct 25, 2024)
- K231130: TumorSight Viz (Dec 26, 2023)

Source page: https://510kreport.com/company/simbiosys