InferOperate Suite
Beijing Infervision Healthcare Medical Technology Co., Ltd.InferOperate Suite is a medical imaging software designed to assist trained professionals in reading and interpreting CT images of the chest, abdomen, and pelvis. It uses machine learning algorithms to segment anatomical structures and provides 3D visualization and surgical planning tools, improving clinical workflow and aiding treatment planning.
Intended Use
InferOperate Suite provides tools to aid trained medical professionals in reading, interpreting, reporting, and treatment planning for adult patients, including preoperative surgical planning and intraoperative image display using DICOM medical images from various devices.
Technology
The software accepts DICOM images, employs machine learning-based algorithms and other image processing techniques for anatomical segmentation, 3D reconstruction, and visualization, and supports both on-premise and cloud deployment.
Performance
Performance was validated on 188 CT cases from various vendors with expert radiologist annotated ground truth. The segmentation showed high accuracy measured by Dice coefficients and Hausdorff distances, consistent with FDA guidance and IEC 62304 software lifecycle standards.
Predicate Devices
No predicate devices specified
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