FDA Radiology AI Devices

Overjet Caries Assist-Pediatric is an AI-powered software designed to assist dentists by automatically detecting and outlining dental caries in bitewing and periapical radiographs of pediatric patients aged 4-11. It provides additional visual cues to support clinical diagnosis but is not a replacement for the dentist's comprehensive review and judgment.

Overjet Periapical Radiolucency Assist is an AI-powered software designed to help dentists detect periapical radiolucencies in dental X-ray images, specifically on periapical radiographs. It provides automated, concurrent read assistance to improve diagnostic accuracy, supporting dentists in identifying potential issues in permanent teeth for patients aged 12 and older. The tool acts as a supplementary aid, enhancing clinical decision-making without replacing professional judgment.

Overjet Caries Assist is an AI-powered software that helps dentists detect and segment dental caries (tooth decay) on bitewing and periapical X-ray images. It provides computer-generated annotations highlighting potential caries to support dentists' diagnosis, improving sensitivity in caries detection. It operates by processing dental radiographs using machine learning models and presenting annotated images in a viewer interface for the dentist. This assists dentists but does not replace professional judgment.

Overjet Calculus Assist is a software tool that helps dentists detect calculus deposits on dental X-rays by automatically highlighting suspicious areas. It supports dentists in diagnosis by providing visual cues on bitewing and periapical radiographs, improving sensitivity to calculus without replacing clinical judgment.

Overjet Caries Assist is an AI-powered software that helps dentists detect and outline tooth decay on bitewing dental X-ray images. It automatically identifies possible caries areas, providing visual annotations to assist dentists in diagnosis and treatment planning. This tool supports dental professionals by improving caries detection sensitivity while allowing them to review and adjust annotations, enhancing diagnostic accuracy without replacing clinical judgment.