FDA-cleared K241984
Hi-D Imaging 4TAVR
Hi-D Imaging AG
Authorized purpose: Pre-procedural cardiovascular anatomy assessment, measurement, visualization, sizing, and planning support for transcatheter aortic valve replacement.
- Modality
- CT/CTA
- Anatomy
- Heart and cardiovascular vessels, including the aortic valve/root, LVOT, annulus, aorta, ventricles, atria, myocardium, and pulmonary artery
- Decision
- 2025-04-02