FDA Radiology AI Devices

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 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.

The Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters are reprocessed ultrasound catheters used in cardiac electrophysiology procedures. They provide real-time 2D ultrasound imaging and 3D location sensing inside the heart and great vessels to help clinicians visualize anatomy and other procedural devices during interventions.

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.

Radius VSM and Accessories is a wearable multi-parameter patient monitor from Masimo Corporation designed for continuous monitoring of vital signs like heart rhythm, blood pressure, oxygen saturation, respiratory rate, and skin temperature. It helps clinicians monitor patients' cardiovascular and respiratory status in hospital settings and includes arrhythmia detection, facilitating timely clinical intervention and patient management.

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.

The OptiMap™ System is a medical device used during electrophysiology procedures to help physicians analyze and visualize complex cardiac arrhythmias. It uses a 64-electrode basket catheter to capture electrogram signals within the heart, which are processed with proprietary algorithms to create detailed maps of electrical flow and activation pathways. This assists clinicians in diagnosing and understanding heart rhythm disorders more effectively.