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.

QLAB Advanced Quantification Software is a tool designed to help clinicians view and measure ultrasound images, specifically focusing on analyzing the heart's right ventricle using advanced automatic segmentation and machine learning. It assists healthcare professionals by providing accurate measurements that improve cardiac assessments without manual contouring for most cases, making the diagnostic process faster and more reliable.

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.

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.

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.

Syngo.Via RT Image Suite is a software tool designed to help clinicians visualize, manipulate, and contour medical images from various imaging modalities such as CT, MRI, and PET. It supports 3D and 4D image visualization and assists with the segmentation of tumors and organs-at-risk to aid in radiation therapy planning and response assessment. The software incorporates AI techniques, including deep learning-based contouring, to improve the accuracy and efficiency of treatment preparation, thereby enhancing patient care in radiation therapy.

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.

AI-Rad Companion (Cardiovascular) is an AI-powered software that analyzes previously acquired CT chest images to segment the heart and aorta, quantify coronary calcium, and measure aortic diameters. It assists clinicians by providing quantitative and qualitative cardiovascular assessments to support diagnosis and evaluation in emergency, specialty, and general practice care.