FDA Radiology AI Devices

PathPresenter Clinical Viewer is a web-based software tool designed to help pathologists view and manage high-resolution digital images of tissue slides. It facilitates diagnosis by allowing detailed image navigation, annotation, and measurement, improving pathology workflow and accuracy.

Us2.ca is a clinical decision support tool that automatically analyzes echocardiogram images to assist cardiologists and healthcare professionals in identifying patients with potential cardiac amyloidosis. It improves clinical workflow by providing AI-derived measurements and report generation, helping clinicians focus on cases needing further follow-up, but it does not replace a formal diagnosis or current care standards.

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 EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are sophisticated diagnostic ultrasound devices that integrate deep learning AI technology to assist clinicians in cardiac imaging. Their Smart View Select software automatically classifies and selects optimal ultrasound images for left ventricle analysis in echocardiography, enhancing workflow and diagnostic accuracy for cardiac assessment. These systems are used by trained healthcare professionals in clinics and hospitals for a broad range of diagnostic ultrasound applications.

The Happy Health Home Sleep Test is a software device that processes data collected from wearable sensors, such as a smart ring, to help healthcare providers evaluate adults suspected of sleep apnea. It records, analyzes, and presents biophysical signals like movement and blood flow to produce sleep parameters including apnea-hypopnea index and total sleep time, aiding clinicians in the diagnosis of sleep-related breathing disorders.

The SKR 3000 is a digital radiography device by Konica Minolta designed to produce high-quality X-ray images of the human body for general-purpose diagnostic procedures. It replaces traditional film-based systems and includes features like advanced image processing and wireless connectivity. Its added indication includes pediatric imaging, helping clinicians accurately diagnose patients of all ages.

RT Elements 4.5 is a computer-based software suite designed to assist clinicians in planning radiation treatments for brain, spine, and extracranial lesions. It supports stereotactic and conformal radiation therapy by providing optimized treatment plans, dose reviews, and AI-based tumor segmentation, helping improve accuracy and efficiency in patient treatment.

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.

uOmniscan is a software that enables real-time remote collaboration and control of medical imaging devices, especially MRI scanners. It helps healthcare professionals remotely manage scans, train technicians, and enhance communication across different locations, increasing workflow efficiency and access to expert guidance.