FDA Radiology AI Devices

This product is a family of Philips MRI systems designed to produce detailed images of the body's internal structures. These MRI machines help doctors and clinicians by providing high-quality images that assist in diagnosing a variety of medical conditions across different body regions without using ionizing radiation.

MROpen Evo is a whole body MRI diagnostic device designed to produce high-resolution images of various body structures in multiple orientations, including brain examination with DWI sequence. It facilitates imaging for patients who might benefit from standing scans or have movement disorders, and incorporates advanced software features like Compressed Sensing for faster image acquisition. The device uses superconducting magnets cooled by a cryocooler and is intended for diagnostic imaging with certain limitations in cardiac, breast, lung, and upper abdominal imaging.

The XENOVIEW 3.0T Chest Coil is a flexible MRI coil designed to work with 3.0T MRI scanners. It is intended for use with hyperpolarized xenon gas inhaled by patients to provide detailed MRI images of lung ventilation. This device helps clinicians evaluate lung function in adult and pediatric patients, enhancing pulmonary imaging capabilities with advanced MRI technology.

1CMR Pro is a medical software tool that helps clinicians view and analyze cardiovascular MRI images. It automates analysis of heart structure, function, and blood flow, improving the accuracy and precision of cardiac assessments. This supports better diagnosis and monitoring of heart diseases.

icobrain aria is a software tool that helps radiologists detect and assess amyloid-related abnormalities in brain MRI scans of Alzheimer's disease patients undergoing antibody treatment. It uses AI to highlight and measure edema and microhemorrhages, aiding in clinical decisions and monitoring disease progression safely and effectively.

TeraRecon Cardiac.Chambers.MR is a software tool designed to automatically segment the anatomical structures of cardiac chambers from contrast or non-contrast cardiac MR scans in adult patients. It helps clinicians by providing precise delineation of the left and right ventricular walls, facilitating faster and more accurate cardiac assessment.

JLK-PWI is a software tool used by trained medical professionals to analyze special types of brain MRI scans called diffusion-weighted and perfusion-weighted images. It helps calculate parameters related to tissue water diffusion and blood flow, assisting clinicians in understanding brain tissue conditions. The software integrates with standard hospital imaging systems and allows for viewing and analysis, aiming to support diagnosis and treatment planning.

The RemedyLogic AI MRI Lumbar Spine Reader is a software tool that automatically analyzes MRI images of the lumbar spine to identify and measure anatomical features. It helps radiologists and spine surgeons by providing quantitative measurements and image segmentations, which can improve the efficiency and accuracy of their analyses and reporting. Users review and adjust the software's outputs before finalizing diagnostic or treatment decisions.

Neurophet AQUA (V3.1) is an automated medical software that analyzes brain MR images to help doctors by labeling, visualizing, and measuring brain structures and lesions. It compares these measurements to reference data, enabling clinicians to assess brain changes or abnormalities more efficiently and accurately.

TumorSight Viz is a cloud-based AI software that helps clinicians visualize and analyze breast MRI images in patients with early-stage or locally advanced breast cancer. It processes dynamic contrast-enhanced MRI data to provide 3D renderings, measurements, and segmentations of tumors, supporting more informed clinical evaluations and treatment planning.