FDA AI Clearance Tracker/K260322
Radiology · 510(k)
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
Mighty Oak Medical
- Device
- Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
- Company
- Mighty Oak Medical
- Submission number
- K260322
- Pathway
- 510(k)
- Decision date
- Jun 11, 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.