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The Imbio RV/LV Software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements. RV/LV analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the ventricles. The RV/LV software provides the user with annotated images showing ventricular measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CTPA cases.

The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The Imbio CT RV/LV Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal. Imbio RV/LV Software is a Software and Medical Device (SaMD) intended to provide annotated images and a PDF report that will be read most typically at a PACS workstation. Imbio RV/LV Software is an aid only used to support a physician in the analysis of CTPA images. The Imbio RV/LV Software program reads in DICOM CPTA image datasets, processes the data, then writes output DICOM files and summary reports to a specified directory. Imbio RV/LV Software outputs DICOMs of the original input DICOM CPTA images overlaid with color-codings representing the results of RV/LV computer caliper measurement. Additionally, a summary PDF report is output. Imbio RV/LV Software does not interface directly with any CT scanner or data collection equipment; instead the software imports data files previously generated by such equipment and is integrated as part of the radiological work-flow, reducing the risk of use errors.

The Imbio Segmentation Editing Tool Software is used by trained medical professionals asa tool to modify the contours of segmentation masks produced by Imbio algorithms or to manually create segmentation mask contours. The Segmentation Editing Tool can provide further support to the users of Imbio's algorithms.

Imbio Segmentation Editing Tool (SET) Software is a segmentation editing tool designed to allow users to optimize segmentations calculated by Imbio's fully-automated suite of algorithms (Each algorithm is a separate Imbio program and either has or will be submitted for regulatory approval independently). Imbio is building a suite of medical image post-processing applications that run automatically after data transfer off the medical imaging scanner. Automatic image segmentation is often an essential step in Imbio's analyses. To date, the automatic segmentation algorithms used in Imbio's applications have been robust, however segmentation failures do occur. The purpose of the Segmentation Editing Tool is to provide customers with a tool to locally correct poor segmentations. Additionally, if the Imbio automatic segmentation fails such that it is unable to produce a result, this tool can be used to semi-manually draw the segmentation required for analysis. SET reads in anatomical images used in an automatic segmentation algorithm and the results of the automated segmentation algorithm (if available). The user is then able to locally correct insufficiencies in the segmentation result, or create a segmentation mask from scratch. The finalized segmentation mask is then pushed back to Imbio's Core Computing Platform and the job is re-processed.