DEN240068
- 510(k) number
- DEN240068
- Device name
- ArteraAI Prostate
- Applicant
- Artera, Inc. CA · US
- Product code
- SFH — Pathology Software Algorithm Device Analyzing Digita
- Decision date
- 2025-07-31
- Date received
- 2024-11-25
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Pathology
Official FDA record: DEN240068
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.