Hi-D Imaging 4TAVR

Hi-D Imaging 4TAVR is a cloud-based software tool that helps cardiologists, radiologists, and clinical specialists plan transcatheter aortic valve replacement (TAVR) procedures. It uses artificial intelligence and computer vision to automatically segment heart and vessel structures from CT scans, generate 3D reconstructions, detect anatomical landmarks, and produce measurements and reports for pre-operative planning in patients with tricuspid aortic stenosis.

Both the subject device (4TAVR) and predicate (3mensio Workstation) are Class II medical image management and processing systems that accept CT data in DICOM format and provide automated segmentation, centerline detection, multiplanar reconstruction, measurement tools, and report generation. The subject device is more specialized and automated for TAVR planning specifically, while the predicate is a broader general-purpose cardiac and vascular visualization platform.

Not stated in this summary.

4TAVR is substantially equivalent because it performs the same core functions as the predicate device—segmentation of cardiac structures, centerline detection, 3D reconstruction, and measurement of anatomical parameters from DICOM CT images—even though 4TAVR is more automated and TAVR-focused. Both are Class II medical image processing systems with identical regulatory classification and product intent to support pre-operative cardiac planning. The differences (full automation vs. manual options, TAVR-specific vs. general cardiac use) do not raise new safety or effectiveness questions because the underlying image processing methods and output types are substantially similar.