K260324
- 510(k) number
- K260324
- Device name
- Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
- Applicant
- Canon Medical Informatics, Inc. MN · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-05-22
- Date received
- 2026-01-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K260324.pdf
Official FDA record: K260324
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.