- Device
- ANDI 2.2
- Company
- Imeka Solutions, Inc.
- Submission number
- K261405
- Pathway
- 510(k)
- Decision date
- May 28, 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.