- Device
- ArteraAI Breast
- Company
- Artera, Inc.
- Submission number
- K254115
- Pathway
- 510(k)
- Decision date
- May 4, 2026
- Specialty (lead panel)
- Pathology
- Primary product code
- SHW
Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.