FDA AI Clearance Tracker/K253628
Radiology · 510(k)
Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)
Agada Medical, Ltd.
- Device
- Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)
- Company
- Agada Medical, Ltd.
- Submission number
- K253628
- Pathway
- 510(k)
- Decision date
- Jun 29, 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.