FDA AI Clearance Tracker/K261289
Radiology · 510(k)
UNiD Spine Analyzer (SW3002)
Medicrea International S.A.S. (Medtronic)
- Device
- UNiD Spine Analyzer (SW3002)
- Company
- Medicrea International S.A.S. (Medtronic)
- Submission number
- K261289
- Pathway
- 510(k)
- Decision date
- May 15, 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.