# Artera, Inc.

- Location (FDA's records): Los Altos, CA
- FDA decisions: 2 (2025–2026): 1 510(k) clearance and 1 De Novo grant
- Product codes: SFH (1), SHW (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- SimBioSys, Inc.: 1 (https://510kreport.com/company/simbiosys)

## Its most-cited devices
- K254115: ArteraAI Breast (2026), cited by 1

## Recent decisions
- K254115: ArteraAI Breast (May 4, 2026)
- DEN240068: ArteraAI Prostate (Jul 31, 2025)

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