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.
Clearance details
- Applicant
- Canon Medical Informatics, Inc.
- Product code
- 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
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