FDA Radiology AI Devices

RadioLens v1.0 by Synapsica is a medical image management and processing system that allows radiologists and medical practitioners to view, analyze, and report on DICOM-format radiology images. The software includes an AI module called SpindleX for automated analysis and measurement of spinal ligament injuries in digital stress X-rays of the cervical and lumbar spine. This helps clinicians by providing quantitative measurements and detailed reports, enhancing diagnostic accuracy and efficiency in spinal injury assessment.

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.

BoneView 1.1-US is an AI-powered software designed to assist clinicians by analyzing X-ray radiographs to identify and highlight fractures. It works as a concurrent reading aid, helping improve the accuracy and speed of fracture diagnosis across multiple anatomical regions including limbs, pelvis, ribs, and spine for both adults and pediatric patients. The software integrates seamlessly with imaging systems like PACS and can be deployed on-premise or in the cloud, enhancing radiologists' ability to detect subtle and definite fractures.

The Xeleris V Processing and Review System by GE Healthcare is a software platform designed for processing, reviewing, and analyzing nuclear medicine and PET imaging data. It supports various clinical applications including brain, lung, cardiac, liver, and bone imaging analyses, aiding physicians in diagnosis and treatment planning by providing enhanced image visualization, quantification, and monitoring of patient radiation doses.

AVIEW Lung Nodule CAD is an AI-powered software designed to help radiologists detect lung nodules on chest CT scans. It automatically identifies nodules between 3 to 20 mm in diameter, providing an additional review layer to ensure suspicious nodules are not overlooked. This tool integrates with medical imaging systems and has been clinically tested to improve detection accuracy and reduce the time radiologists spend reviewing CT scans, ultimately aiding early diagnosis of lung conditions.

Videa Perio Assist is an AI-powered software that helps dentists and dental hygienists measure and visualize bone levels between teeth using bitewing and periapical dental X-rays. It provides precise measurements that support evaluations related to periodontal health but is not meant to replace full clinical diagnosis.

BriefCase is an AI-powered software by Aidoc Medical that automatically analyzes chest CT scans to identify cases with three or more acute rib fractures. It sends notifications with preview images to help radiologists prioritize these critical cases for faster review, enhancing clinical workflow and patient care without altering original images or providing primary diagnoses.

Rapid RV/LV is a medical imaging software designed to assist clinicians by automatically measuring the sizes of the right and left heart ventricles from CT pulmonary angiography scans. It provides annotated images and quantitative measurements to help assess right-heart strain, supporting clinical decision-making in cardiopulmonary conditions. The software uses machine learning to locate the ventricles and report their size ratio.

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.

Syngo Dynamics (Version VA40F) is a software medical device from Siemens designed to assist healthcare professionals in reviewing and analyzing medical images for disease detection and patient management. It supports multiple imaging modalities including ultrasound, x-ray angiography, CT, MR, nuclear medicine, and others, with applications primarily focused on cardiology, vascular, and fetal imaging. The software offers advanced image processing tools and semi-automated measurement capabilities such as left ventricular ejection fraction estimation, helping clinicians interpret complex imaging data efficiently within healthcare networks.