- Device
- ADAS 3D
- Company
- Adas3D Medical S.L.
- Submission number
- K253969
- 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.