FDA Radiology AI Devices

AmCAD-UO is a software application designed to analyze ultrasound images of the upper airway. It helps physicians visualize and quantify airway size, position, and tissue characteristics to monitor airway conditions more effectively. It supports manual and interactive region selection for detailed analysis and is intended to assist clinical evaluation, not to be used as a sole diagnostic tool.

iSchemaView RAPID is a software package that helps medical professionals view and analyze CT and MRI images, particularly to evaluate stroke patients for endovascular thrombectomy. It provides advanced image processing for perfusion, diffusion, and angiography to aid clinical decision-making.

Quantib ND is an AI-powered software that processes MRI brain scans to automatically identify and measure volumes of various brain structures and white matter hyperintensities. It provides 3D visualizations and quantitative data to assist medical professionals in evaluating brain images and supporting quantitative reporting, making brain MR image assessment more precise and efficient.

vascuCAP is a medical image analysis software designed to help clinicians process and evaluate multidimensional CT images of arterial vessels. It provides tools to visualize vessels in 3D and measure key anatomical features such as lumen boundaries, vessel stenosis, and plaque characteristics. This assists physicians in stratifying patients with atherosclerosis by providing detailed vessel information to complement standard care.

Centricity Universal Viewer by GE Healthcare is a medical imaging software solution designed to display, manage, analyze, and share medical images from multiple imaging modalities. It facilitates radiologists and cardiologists in interpreting diagnostic images, improving workflow and clinical decision-making. It supports many imaging formats but is not intended for digital pathology diagnosis. The product enhances clinicians' ability to view and interpret images efficiently across healthcare systems.

PowerLook Tomo Detection V2 Software by iCAD Inc. is an AI-based computer-assisted detection and diagnosis tool that helps physicians identify suspicious lesions and calcifications in digital breast tomosynthesis images. It provides confidence scores to assist in evaluating findings, improving radiologist accuracy and reducing reading time during breast cancer screening exams.

The AMRA Profiler is a medical imaging system that utilizes MRI technology to assess body composition. It helps clinicians by providing detailed imaging data that supports diagnostics or treatment planning in radiology.

SubtlePET is a software product that uses deep neural network-based AI algorithms to reduce noise and enhance the structural quality of PET images, including PET/CT and PET/MRI scans. It integrates into existing clinical workflows by acting as a DICOM node to process and forward enhanced images, helping radiologists and nuclear medicine physicians better visualize and analyze PET scans for improved diagnostic confidence.

FerriSmart is a medical software that automatically analyzes MRI scans of the liver to measure iron concentration. This helps doctors diagnose and monitor patients with iron overload diseases, such as thalassemia or sickle cell disease, making treatment decisions more accurate and timely.

Transpara is an AI-powered software tool that helps doctors identify suspicious areas in mammograms that might be breast cancer. It highlights these areas, provides scores indicating the likelihood of cancer, and supports physicians in making more accurate diagnoses. This assists in earlier and more reliable detection of breast cancer during screening.