Radiology DICOM image processing application software

Intended purpose

The software is indicated for use as a general imaging system. It is intended to be used to acquire, store, transmit and display images from medical scanning devices. Specific indications for use for the software are the display of a composite view of 2D cross-sections, and 3D volumes of chest CT images, including findings or regions of interest (“ROI”) identified or Computer Assisted Detection (“CAD”) findings. The CAD system is a Computer-Aided Detection (CAD) system designed to assist radiologists in the detection of solid pulmonary nodules during review of multidetector CT (MDCT) scans of the chest. It is intended to be used as an adjunct, alerting the radiologist – after his or her initial reading of the scan – to regions of interest (ROIs) that may have been initially overlooked.