- Device
- MammoScreen® (5)
- Company
- Therapixel
- Submission number
- K260714
- Pathway
- 510(k)
- Decision date
- Jun 26, 2026
- Specialty (lead panel)
- Radiology
- Primary product code
- QDQ
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.