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The syngo.CT Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid pulmonary nodules during review of multi-detector computed tomography (MDCT) examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may have been initially overlooked. The syngo. CT Lung CAD device is intended to be used as a second reader after the radiologist has completed his/her initial read.

syngo.CT Lung CAD is a medical device that is designed to perform CAD processing in thoracic CT examinations for the detection of solid pulmonary nodules ≥ 3 mm in size. The device processes images acquired with Siemens multi-detector CT scanners with 4 or more detector rows. The syngo.CT Lung CAD device supports the full range of nodule locations (central, peripheral) and contours (round, irregular). The detection performance of the syngo.CT Lung CAD device is optimized for nodules between 3 mm and 10 mm in size. Additionally, the syngo.CT Lung CAD device can be used in scans with or without contrast enhancement. The device receives images via an input data interface, performs CAD processing and provides locations of suspected nodules as an output. Specific visualizations, such as the syngo PET&CT Oncology application (K093621) or equivalent Siemens products, should be used (but are not part of this clearance) to display the CAD marks. The syngo.CT Lung CAD device is intended to be used as a second reader only after the initial read is completed.