# K191585: iNtuition-Structural Heart Module

- Pathway: 510(k) (Traditional)
- Applicant: Terarecon,Inc.
- Decided: Jul 12, 2019 after 28 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K913770 (1991). 66 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153736: 3mensio Workstation, Pie Medical Imaging BV (2016) Summary page 4.
- K121916: Intuition, Terarecon,Inc. (2013) Summary page 4.

## Most influential descendants
- K250337: AiORTA - Plan (2025), 1 descendant of its own
- K254207: AiORTA - Plan v2.0 (2026), 0 descendants of its own

## Indications for use
iNtuition-Structural Heart Module is a software solution that is intended to assist Cardiologists, Radiologists and Clinical Specialists with the visualization and measurements of structures of the heart and vessels. iNtuition-Structural Heart Module enables the user to: * Visualize and measure (diameters, lengths, angles, areas and volumes) structures of the heart and vessels for pre-operative planning and sizing for cardiovascular interventions and surgery, and for post-operative evaluation. * Quantify calcium (volume, density) iNtuition-Structural Heart Module has the following tools and features that facilitate: » Automatic and manual centerline detection. » Segmentation of cardiovascular structures. » Measurement tools (diameters, lengths, areas, volumes, angles) for the dimensions of vessels and structures. * Calcium quantification and scoring. Various visualization techniques: 2D/3D/4D visualization, MPR, Curved MPR, Stretched MPR, MIP, MinIP, Raysum and MAR. * Capture and Report.

Source page: https://510kreport.com/device/K191585
Methodology: https://510kreport.com/methodology