K254115
- 510(k) number
- K254115
- Device name
- ArteraAI Breast
- Applicant
- Artera, Inc. CA · US
- Product code
- SHW — Pathology Software Algorithm Device Analyzing Digita
- Decision date
- 2026-05-04
- Date received
- 2025-12-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Pathology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K254115
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.