FDA Radiology AI Devices

PIUR tUS inside is a medical device that enhances standard 2D ultrasound devices by generating three-dimensional (3D) tomographic ultrasound volumes of the thyroid. It assists physicians in diagnosing thyroid nodules by providing volumetric information, segmentation, and quantification of sonographic characteristics. This device operates directly on compatible ultrasound scanners, integrating sensor data to create 3D images that support clinical decision-making as an add-on to regular ultrasound imaging.

CardIQ Suite is a non-invasive software that analyzes cardiac CT scans to visualize heart vessels, measure calcium deposits, and evaluate heart fat volume. It helps clinicians diagnose cardiovascular diseases, monitor disease progression, and plan treatment by providing detailed vessel measurements and calcium scoring from cardiac CT images.

The 6600 Ultrasound System (MyLabA50 and MyLabA70) by Esaote is a multifunctional ultrasound scanner designed for use in various clinical applications such as cardiac, vascular, general imaging, and women's health. It uses advanced ultrasound modes like B-mode, Doppler, elastosonography, and 3D/4D imaging to help clinicians collect, display, and analyze high-quality ultrasound images, supporting diagnosis and patient care. The system includes AI-powered features for automatic obstetric biometric measurements and automatic cardiac measurements, assisting clinicians by enhancing measurement accuracy and workflow efficiency.

The Shear Wave Quantificational Ultrasound Diagnostic System is a portable ultrasound device designed to measure liver tissue stiffness using shear wave elastography and estimate tissue characteristics such as Ultrasound Attenuation Parameter (UAP). It provides non-invasive aid in diagnosing, managing, and monitoring adult and pediatric patients with liver diseases by delivering both ultrasound images and quantitative data on liver health. The system helps clinicians assess liver conditions efficiently and accurately in a clinical setting.

The Accuro® 3S Needle Guide Kit by Rivanna Medical, Inc. is a sterile, disposable accessory designed for use with the Accuro® 3S ultrasound imaging system. It helps healthcare professionals accurately align needles with the ultrasound imaging plane during procedures, stabilizing the needle guide position and isolating the needle insertion site from contaminants. This aids in precise anatomical targeting and improved procedural safety.

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.

TraumaCad Neo (1.1) is software that helps surgeons plan and evaluate orthopedic procedures by using X-ray images. It overlays measurements and prosthesis templates to assist in surgical planning and postoperative assessment, including automated analysis of hip arthroplasty outcomes using AI. This streamlines workflow and supports clinical decisions prior to and after surgery.

AudaxCeph Cephalogram Analysis Software is a specialized software intended for dental professionals to assist in treatment planning by analyzing 2D cephalogram images. It automatically detects landmarks on images, allows measurement and superimposition, and supports orthodontic treatment planning. The software can be used as a desktop application or via the cloud, helping clinicians make informed decisions by digitizing and analyzing dental radiological images efficiently.

The Europa (AiRTouch) portable X-ray system is a mobile diagnostic device designed for imaging extremities in both adult and pediatric patients aged 12 and older. It produces high-quality X-ray images using adjustable tube current and voltage and supports image capture through film or digital receptors. This system is portable, battery-operated, and intended for use by trained clinicians, facilitating easier and flexible diagnostic imaging outside traditional radiology suites.

Rapid MLS is an AI-powered software that analyzes non-contrast CT scans to measure and visually display brain midline shifts. This helps clinicians assess conditions like intracranial hemorrhage and traumatic brain injury by providing quantitative and annotated images, supporting but not replacing clinical decision-making.