Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning— 510(k) K260324
Substantially EquivalentCanon Medical Informatics, Inc.
FDA 510(k) clearance K260324 for Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning, Substantially Equivalent on 2026-05-22. Applicant: Canon Medical Informatics, Inc..
Clearance details
- Applicant
- Canon Medical Informatics, Inc.
- Product code
- Code QIH
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minnetonka, MN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.