- Device
- Synapse Lung Nodule AI
- Company
- Fujifilm Corporation
- Submission number
- K254075
- Pathway
- 510(k)
- Decision date
- May 27, 2026
- Specialty (lead panel)
- Radiology
- Primary product code
- OEB
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.