- Device
- Enhanced Boundary for PCCT
- Company
- Ge Medical Systems, LLC
- Submission number
- K253560
- Pathway
- 510(k)
- Decision date
- Jun 24, 2026
- Specialty (lead panel)
- Radiology
- Primary product code
- JAK
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.