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.

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.

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.

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.

Spine CAMP™ is a fully-automated software that analyzes X-ray images of the spine to measure and assess spinal parameters, such as alignment, stability, and motion. It helps healthcare professionals by providing quantitative metrics and visualizations, improving clinical decision-making regarding spinal health and treatments.

QIR Suite is a software tool designed to help medical professionals analyze cardiovascular magnetic resonance images. It uses standard and deep learning algorithms to automate measurements like heart chamber function and blood flow, aiding diagnosis and treatment planning for adult patients with heart conditions.

Viz RV/LV is a software tool that uses artificial intelligence to automatically measure the size of the right and left ventricles of the heart from CT pulmonary angiogram scans. It provides annotated images and a summary report to assist clinicians in evaluating right ventricular enlargement, potentially aiding diagnosis and treatment decisions.

The EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System is an AI-powered software that automatically measures the cardiothoracic ratio from chest X-ray images in the posterior-anterior view. It helps physicians by automatically calculating a key heart size measurement, supporting clinical assessments in hospitals and clinics for adult patients.

The Caption Interpretation Automated Ejection Fraction Software is an AI-powered tool that automatically analyzes previously acquired cardiac ultrasound images to estimate the left ventricular ejection fraction. This helps clinicians assess heart function more efficiently and accurately by providing automated measurements, confidence metrics, and video clip visualizations within compatible ultrasound or PACS systems.

Follicle Clarity is a cloud-based AI software that helps clinicians by automatically detecting and measuring the number and size of ovarian follicles from transvaginal ultrasound images. It provides graphical and tabular summaries of these measurements to assist in fertility monitoring and related clinical decisions.