- Device
- EchoNext
- Company
- Pathwai, Inc.
- Submission number
- K260332
- Pathway
- 510(k)
- Decision date
- Jun 8, 2026
- Specialty (lead panel)
- Cardiovascular
- Primary product code
- QXO
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.