iNtuition-Structural Heart Module
TeraRecon Inc.The iNtuition-Structural Heart Module by TeraRecon is a software tool designed to help cardiologists and radiologists visualize and measure structures of the heart and vessels. It supports image analysis, quantification of calcium, and provides detailed 2D/3D/4D visualizations to plan and evaluate cardiovascular interventions and surgeries, aiding clinicians in improved patient care.
Intended Use
iNtuition-Structural Heart Module is a software solution intended to assist cardiologists, radiologists and clinical specialists with visualization and measurements of structures of the heart and vessels for pre-operative planning, sizing for cardiovascular interventions and surgery, post-operative evaluation, and calcium quantification.
Technology
The device is an optional image post-processing software module working with iNtuition, providing features such as automatic and manual centerline detection, segmentation, measurement tools (diameters, lengths, areas, volumes, angles), calcium quantification, and various visualization techniques (2D/3D/4D, MPR, MIP, MinIP, Raysum, MAR). It supports review and reporting, interactive image assessments, and runs on Windows-based stand-alone workstations or servers accessible locally or remotely via thin clients or web viewers.
Performance
No clinical studies were required; performance was validated through verification and validation testing per internal protocols ensuring the software meets all design requirements and is substantially equivalent to predicate devices. Risk mitigation and software verification/validation ensure safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/14/2019
28 days - 2
FDA Approval
7/12/2019
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