FDA AI Clearance Tracker/K260324
Radiology · 510(k)
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
Canon Medical Informatics, Inc.
- Device
- Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
- Company
- Canon Medical Informatics, Inc.
- Submission number
- K260324
- Pathway
- 510(k)
- Decision date
- May 22, 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.