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.

Smile Dx® is an AI-powered software that assists dentists by analyzing dental X-ray images to detect issues like cavities, periapical radiolucencies, restorations, and measures bone levels. It supports digital and phosphor sensors, enhancing diagnosis and treatment planning by highlighting suspected dental findings for review, but it does not replace a dentist's judgment.

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.

Lung AI (LAI001) is a software tool that assists healthcare professionals by analyzing lung ultrasound scans to detect signs of consolidation/atelectasis and pleural effusion. It highlights regions of interest on ultrasound cine clips to help clinicians identify potential lung issues, improving review efficiency but not replacing clinical judgment or other diagnostic tests. It supports physicians particularly in emergency departments during point-of-care lung ultrasounds.

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.

Rayvolve LN is an AI-powered software that helps radiologists detect and highlight suspected pulmonary nodules on frontal chest X-rays. By serving as a second reader, it aids in reviewing digital radiographs for patients 18 years or older, enhancing diagnostic accuracy without replacing the original chest images.

Better Diagnostics Caries Assist (BDCA) Version 1.0 is an AI-powered software tool that helps dentists automatically identify and mark areas of tooth decay (caries) on dental x-rays (bitewing and periapical). It provides visual annotations to support the dentist's diagnosis, improving the accuracy and efficiency of caries detection but does not replace clinical judgment or complete review.

ChestView US is an AI software product that analyzes frontal and lateral chest X-rays to detect and mark suspicious areas such as lung nodules, pleural abnormalities, mediastinal/hilar abnormalities, and consolidations. It provides annotated images with highlighted regions to assist clinicians in reading chest radiographs, improving diagnostic accuracy as a concurrent reading aid.

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.

Velmeni for Dentists (V4D) is a computer-assisted detection software that helps dentists identify dental caries, restorations, fixed prostheses, and implants in various types of dental radiographs such as bitewing, periapical, and panoramic images. It uses machine learning algorithms to analyze radiographs and highlight areas of interest, providing additional information to aid clinical decisions without replacing dentist judgment.