X-ray image interpretive software

Intended purpose

The Software is a clinical decision support, computer aided diagnostic (CADx) software application intended for analysis of computed tomography (CT) scans of the lung. The software compares physician-selected nodules against a clinically established database of lung nodules and provides a similarity score to assist clinicians’ assessment of patients’ cancer risk. The Software is designed to be used by radiologists and other healthcare practitioners who are licensed to make diagnostic or other follow-up decisions using radiological imagery and/or radiology reports. The information provided by the Software should only be used in conjunction with other clinically accepted information to guide medical decision-making at the discretion of the clinician.