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.. Device class: 2.
Summary
Canon Medical Informatics' Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is filed under QIH, automated radiological image processing software.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Canon Medical Informatics filed from Minnetonka, Minnesota. Review took 112 calendar days (January 30 to May 22, 2026).
Clearance details
- Applicant
- Canon Medical Informatics, Inc.
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minnetonka, MN, US
Recent devices under product code QIH
view allMore clearances from Canon Medical Informatics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.