- Device
- Brainomix 360 Hyperdensity
- Company
- Brainomix Limited
- Submission number
- K260406
- Pathway
- 510(k)
- Decision date
- Jun 12, 2026
- Specialty (lead panel)
- Radiology
- Primary product code
- QIH
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.