FDA AI Clearance Tracker/K261713
Radiology · 510(k)
Synapse PACS (7.6.0)
FUJIFILM Healthcare Americas Corporation
- Device
- Synapse PACS (7.6.0)
- Company
- FUJIFILM Healthcare Americas Corporation
- Submission number
- K261713
- Pathway
- 510(k)
- Decision date
- Jun 18, 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.