FDA Radiology AI Devices

ADAS 3D is a software application designed to help medical professionals visualize and analyze 3D cardiac images obtained from MRI and CT scans. It supports the quantification and visualization of myocardial scar and other cardiac features to assist clinical decision-making for patients with cardiovascular disease. The software enables detailed analysis of the heart's structure and enhancement patterns, facilitating better cardiovascular disease assessment.

Icobrain is an AI software tool that helps clinicians automatically identify, label, and measure brain structures and abnormalities using MRI or CT images. It supports tracking changes in brain volumes over time, aiding diagnosis and monitoring of brain diseases such as dementia or traumatic brain injury.

QyScore Software is an automated medical image processing software that analyzes brain MRI scans to segment and measure brain structures and lesions. It generates an electronic report and overlays segmentations on images, helping clinicians quantify brain volumes compared to a healthy reference population. This assists in assessment and monitoring of brain health in patients aged 20 to 90 years.

RSI-MRI+ is software designed to assist clinicians by automatically processing diffusion-weighted and anatomical MRI images. It enhances the visibility of restricted diffusion areas, fuses these with anatomical images, and uses AI to segment and quantify the prostate, providing helpful reports. This helps radiologists and urologists more efficiently analyze prostate MRI data.

MEDIP PRO is a medical imaging software that helps clinicians by processing CT and MRI images. It provides tools for segmenting images, improving image quality, and creating 3D reconstructions that can be exported for 3D printing to aid in preoperative planning. The software is intended to be used alongside other diagnostic tools and clinical judgement to support treatment planning.

Cleerly Labs is a web-based software application that helps trained medical professionals view and analyze cardiac CT images, specifically from Coronary Computed Tomography Angiography (CCTA). It assists in identifying and measuring coronary artery plaques and stenosis to help evaluate coronary artery disease or suspected CAD, providing detailed visualizations and measurements to support clinical decision-making.

SIS Software Version 3.6.0 is an advanced medical imaging application designed to assist neurosurgeons, neurologists, and radiologists by processing MRI and CT scans to create detailed 3D models of brain structures, particularly the subthalamic nuclei. It uses machine learning to enhance images, aiding in the visualization and planning of stereotactic brain surgeries, thereby improving surgical accuracy and patient outcomes.

D2P is a software tool developed by 3D Systems that processes medical imaging data (DICOM) to create 3D segmentations and physical models. It assists clinicians in surgical planning by allowing the generation of accurate physical replicas of anatomical regions from imaging data, supporting diagnosis and treatment decisions in cardiovascular, craniofacial, gastrointestinal, genitourinary, neurological, and musculoskeletal areas.

The iNtuition-Structural Heart Module by TeraRecon is a software tool designed to help cardiologists and radiologists visualize and measure structures of the heart and vessels. It supports image analysis, quantification of calcium, and provides detailed 2D/3D/4D visualizations to plan and evaluate cardiovascular interventions and surgeries, aiding clinicians in improved patient care.

SIS Software version 3.3.0 is a medical imaging application that assists clinicians, including surgeons and neurologists, by enhancing and visualizing brain MRI images, specifically the subthalamic nucleus (STN). It uses AI and image processing techniques to create 3D models and supports image fusion and co-registration between MRI and CT scans to guide stereotactic surgical procedures more accurately.