FDA Radiology AI Devices

ElucidVivo A.3 is a medical image analysis software that processes and visualizes CT angiographic images to help physicians assess arterial vessels and stratify patients with atherosclerosis. It offers tools for measurement and visualization of vessel structure and plaque characteristics, supporting clinical decision-making without providing direct diagnosis.

SwiftMR is a software device that automatically enhances MRI images by reducing noise and increasing image sharpness using deep learning algorithms. It supports brain, spine, and musculoskeletal MRI images and integrates with existing PACS systems to improve diagnostic image quality without interrupting clinical workflow.

Quantib Prostate is an AI-powered image post-processing software designed to assist medical professionals in analyzing prostate MRI scans. It provides tools for visualization, semi-automatic segmentation of prostate anatomy and lesions, volume computations, and PI-RADS scoring support to facilitate the interpretation of prostate MR studies, aiding clinical decision-making.

Segment 3DPrint is a medical software developed by Medviso AB that helps clinicians review and segment images from medical scanners to generate detailed 3D models. These models assist doctors with visualization, measuring, and treatment planning, particularly in orthopaedic, maxillofacial, and cardiovascular fields. The software also supports creating physical 3D printed replicas from these models, enhancing clinical workflows and patient care.

aPROMISE X is a software platform for healthcare professionals and researchers that assists in accepting, transferring, storing, manipulating, quantifying, and reporting digital medical images from PSMA PET/CT scans. It allows users to visualize multiple scans, mark regions of interest, and perform quantitative analysis to help identify suspicious lesions in oncology cases, improving clinical efficiency and consistency.

ClariPulmo is a software tool designed to analyze lung CT images. It helps doctors by automatically segmenting the lungs and quantifying areas of low and high attenuation in the lung tissue. It includes AI-based features like deep learning segmentation, denoising, and kernel normalization to improve image quality and quantification, especially for low-dose CT scans. This software supports clinical assessment of lung abnormalities by providing color-coded images and quantitative reports.

Rapid is a medical image processing software that helps clinicians visualize and analyze tissue changes in CT and MRI images, particularly aiding in the selection of acute stroke patients for treatment. It uses AI/ML components to detect image artifacts and supports advanced imaging features such as perfusion, diffusion and dynamic contrast analysis.

Quantib ND is a software application that automatically labels, visualizes, and measures volumes of brain structures and white matter abnormalities from MR brain scans. It helps radiologists by providing detailed quantitative data and visual segmentations to assist in assessing and tracking neurological conditions.

The UNiD Spine Analyzer is a web-based software tool that helps surgeons and healthcare providers view and measure spine-related medical images, plan surgical procedures, and simulate surgical strategies. It incorporates machine learning predictive models to assist in preoperative planning and includes a database of implant templates to aid in selecting and placing surgical implants. The software enhances clinical decision-making by providing quantitative radiographic parameters and predictive outputs for spine surgery planning.

AIBOLIT 3D+ is a software system that takes CT scan images and processes them into detailed 3D visual models of anatomical structures. This tool helps doctors plan surgeries, train, and educate patients by enabling interactive viewing of organs and tissues from multiple angles and with enhanced clarity. It supports better decision-making and may reduce errors during procedures.