FDA Radiology AI Devices

Second Opinion® CS is a computer-aided detection software designed to help dental health professionals detect and segment caries in radiographs of permanent teeth. Using AI and machine learning, it highlights potential caries lesions and provides detailed analysis on their overlap with tooth structures, improving diagnostic accuracy and assisting clinicians in reviewing dental images.

Second Opinion® 3D is an AI-powered software that helps dental professionals by automatically identifying and marking important anatomical structures in dental CBCT (Cone Beam Computed Tomography) radiographs. It highlights areas such as dentition, maxilla, mandible, and other key dental anatomical features, supporting clinicians to review images more efficiently and accurately. The software acts as a concurrent and second reader for patients aged 12 years or older, assisting in dental evaluation without replacing full clinical patient assessment.

Second Opinion BLE is a software tool that uses AI to help dental professionals measure bone levels in bitewing and periapical radiographs. It assists clinicians by automatically detecting and displaying bone level measurements to aid in patient assessment, but it is not intended to replace full clinical evaluation.

Second Opinion® Pediatric is an AI-driven software designed to assist dental clinicians in detecting caries in bitewing and periapical radiographs of patients aged 4 years and older. It uses machine learning to identify and visually overlay potential caries lesions on dental X-rays, helping clinicians with improved detection accuracy without replacing professional judgment.

Second Opinion Periapical Radiolucency Contours is an AI-based computer-aided detection software that helps dentists identify areas of periapical radiolucency in dental X-rays by outlining suspected regions with polygonal contours. It supports dental professionals by providing a second opinion when reviewing periapical radiographs, potentially improving detection accuracy and aiding clinical decisions.

Second Opinion CC is a specialized AI software designed to assist dental professionals in identifying dental caries on bitewing and periapical radiographs. It processes dental X-ray images and highlights potential caries regions using polygonal contours, helping clinicians review images more effectively as a second reader without replacing their clinical judgment.

Second Opinion is an AI-based software designed to assist dental professionals by automatically detecting and highlighting potential dental issues, such as caries and restorations, on bitewing and periapical radiographs. It acts as a second reader, improving diagnostic accuracy and helping clinicians identify abnormalities more effectively.