FDA Radiology AI Devices

CAC Software by Imbio, Inc. is a machine learning-based post-processing tool that analyzes non-contrast CT images of the chest to assess calcified plaques in the coronary arteries. It quantifies the calcification burden by producing scores and metrics that help clinicians evaluate coronary artery disease risk. The software outputs annotated images and a detailed report, integrating into the standard DICOM workflow to assist physicians without making standalone diagnoses.

The Imbio CT Lung Density Analysis Software assists physicians by automatically processing CT scans of the lungs to quantify lung tissue density and identify abnormalities. It provides tools for 3D segmentation, volumetric analysis, and reporting, helping in diagnosis and monitoring of pulmonary conditions.