Clearance Summary
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning received FDA 510(k) clearance under submission number K260324, sponsored by Canon Medical Informatics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2026-05-22.
- Submission: K260324
- Applicant / Sponsor: Canon Medical Informatics, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2026-05-22
Classification & Regulation
This clearance is catalogued under FDA product code QIH and 21 CFR 892.2050, within the Radiology review panel as a Class II device.