Pursuant to Regulation 21 CFR § 892.2050, Imago Systems has developed a medical image enhancement software for post-processing digital images from multiple imaging sources, referred to as the Imago Image Characterization Engine (Imago ICE™). The patented software algorithms provide post-processed images that present enhanced visualization of pixel information, resulting in greater visualization of vessel structure within the images compared with the grayscale images. The Imago ICE Insight Software is the application of this technology to Digital X-ray Angiography as an image manipulation software tool.
The ICE Insight Software is intended to aid physicians in their clinical review and analysis of coronary angiograms. The enhanced images are intended to aid the reader in seeing greater detail of features and structures, often barely visible in the original image, in their clinical review and analysis of Coronary Artery Disease (CAD) by improving contrast and enhancing edges. ICE Insight-enhanced images are always used in conjunction with the original angiogram image, providing an additional tool for physicians to assist in their assessment of areas of interest of CAD.
Imago Insight Visual Intelligence provides two additional views for cardiologists to examine angiographic data.