Dental x-ray image interpretive software

Intended purpose

Align X-ray Insights is a computer aided detection ("CADe”) software product that aids dental practitioners in the detection and analysis of dental radiographic image data for dental conditions for permanent dentition. The product is used in a professional dental practice environment by dental practitioners. Align X-ray Insights analyzes bitewing, periapical, and panoramic radiographs using a set of artificial intelligence (AI)-based algorithms to assist in the detection of suspected radiographic abnormalities (caries, periapical radiolucencies, periodontal bone loss, and dental calculus), and other radiographic findings (dental fillings, dental crowns, dental implants, dental bridges, root-canal fillings, proximity of lower molars to mandibular canal, and impacted teeth). The classification and segmentation of teeth is used for tooth charting and reporting. The results of Align X-ray Insights are intended to be used in conjunction with evaluation of other patient and clinical information including examination of radiographs as determined by the dentist’s clinical standard of care and should not be solely relied upon to make or confirm a diagnosis.