FDA Radiology AI Devices

The LungVision System is a medical imaging software that helps doctors navigate tools inside the lungs during procedures. It works by segmenting CT scan data and overlaying it on live X-ray images to guide catheter placement accurately, improving procedural safety and effectiveness.

AmCAD-UV is a software tool designed to analyze flow Doppler ultrasound images by classifying ultrasonic color intensity data into different pulsatile signals. It helps clinicians visualize and evaluate vascular pulsatility by providing color-coded images and trend charts of pulsatile signals, although it is not intended for primary diagnostic use by itself.

SIS Software is designed to help medical professionals such as surgeons, neurologists, and radiologists visualize and plan surgeries targeting brain structures, particularly the subthalamic nucleus. It uses machine learning and image processing to enhance standard MRI images and create patient-specific 3D models of brain anatomy, supporting safer and more precise stereotactic surgical procedures.

Quantib Brain 1.2 is a software tool that assists radiologists by automatically identifying and measuring different brain structures and white matter abnormalities from MRI scans. It provides visualizations and quantitative data to support evaluation and reporting, enabling better assessment of brain health over time by comparing multiple scans of the same patient.

Arterys Cardio DL is an AI-powered software that analyzes cardiovascular MRI scans to quantify blood flow and heart function. It helps cardiologists and radiologists by providing clinically relevant, reproducible quantitative data from MRI images, supporting clinical decision-making without giving direct medical advice.

ClearView cCAD is an AI-powered software tool that helps physicians analyze breast ultrasound images by automatically classifying lesion shape and orientation characteristics. It supports better screening and diagnosis by generating reports compliant with ACR BI-RADS standards, aiding radiologists in their assessment without replacing primary diagnostic interpretation.

CT CoPilot is an AI-powered software designed for automatic labeling, visualization, and volume measurement of brain structures from CT scans. It helps radiologists by automating the manual process of analyzing brain CT images, providing detailed segmentation and volumetric data to assist in clinical assessments and comparisons across multiple imaging sessions.

The Clarius Ultrasound System is a portable ultrasound imaging device that wirelessly connects to smartphones or tablets, allowing medical professionals to perform real-time ultrasound scans for various clinical applications such as emergency triage, procedure guidance, fetal imaging, and musculoskeletal assessment. It supports multiple probes and is designed for use by trained healthcare providers in clinical settings.

QVCAD System by QView Medical, Inc. is a specialized AI software that aids radiologists in detecting breast lesions in 3D automated breast ultrasound images. It uses advanced image pattern recognition and neural networks to highlight suspicious areas that may indicate breast cancer, helping clinicians improve detection accuracy and reduce interpretation time during breast screening, especially for women with dense breasts.

PixelShine is a software application that improves the quality of CT images by reducing noise, making them clearer to assist radiologists and specialists in diagnosing patients. It connects to existing CT imaging systems, processes the images, and sends enhanced images back for review, facilitating better clinical decisions.