FDA Radiology AI Devices

The Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems by Philips are advanced 1.5 and 3.0 Tesla MRI machines that produce high-quality cross-sectional images to help physicians diagnose various conditions. They include AI-enhanced features like SmartSpeed AI for faster image acquisition without loss of quality, aiding clinicians with quicker and improved diagnostic imaging.

MAGNETOM Skyra Fit is a 3 Tesla MRI system by Siemens designed to produce detailed transverse, sagittal, coronal, and oblique cross-sectional magnetic resonance images and spectra of the head, body, and extremities. It assists clinicians by providing high-quality images and physical parameters helpful for diagnosis, and can also support imaging during interventional procedures.

The MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A are advanced MRI diagnostic systems that produce detailed cross-sectional images and spectra of the head, body, or extremities. The device uses sophisticated MRI pulse sequences and integrates deep learning-based reconstruction algorithms to produce high-quality images quickly and reliably, aiding physicians in diagnosis and in planning interventional procedures.

The Philips Incisive CT is an advanced whole-body computed tomography system used to acquire detailed images of the head, body, heart, and vascular structures. It helps clinicians diagnose various conditions and supports low-dose lung cancer screening, improving patient care by providing high-quality diagnostic images efficiently.

RayStation 11B is a radiation therapy treatment planning software that helps clinicians create, analyze, and manage radiation treatment plans for cancer patients. The software integrates imaging data, including CT and CBCT, to compute radiation doses accurately and supports the administration of treatments, improving clinical workflow and patient care.

The Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit is a 3 Tesla MRI system that produces detailed cross-sectional images of the head and body. It incorporates AI-powered image reconstruction (AiCE) and machine learning technologies to improve image quality, reduce artifacts, and assist in scan planning, helping clinicians obtain clearer and more precise diagnostic images efficiently.

The MAGNETOM Avanto Fit is a 1.5 Tesla magnetic resonance imaging (MRI) system that produces detailed images of the head, body, and extremities. It helps clinicians visualize internal structures and functions non-invasively, potentially including functional information, and can be used during interventional procedures. The device incorporates advanced hardware and software features to enhance image quality and operational efficiency.

The MAGNETOM Vida with syngo MR XA50A is an MRI system that produces detailed cross-sectional images and spectra of the head, body, or extremities to assist clinicians in diagnosis. It incorporates advanced AI-based image reconstruction algorithms such as Deep Resolve Swift Brain and Deep Resolve Boost to enable faster and higher-quality MRI scans, improving diagnostic workflows and patient outcomes.

Deep Learning Image Reconstruction (DLIR) by GE Medical Systems is an AI-powered CT image reconstruction method that uses a deep neural network to produce high-quality cross-sectional images of the head and whole body. It supports multiple CT acquisition types and enhances image quality by reducing noise and artifacts, helping clinicians get clearer and more accurate imaging results.

The Revolution Ascend is a CT scanner designed to generate detailed cross-sectional images of various body parts including the head, whole body, cardiac, and vascular areas. It uses x-ray transmission data taken at different angles and planes. The device supports multiple acquisition modes and post-processing of images, aiding clinicians in diagnosing disease, trauma, and abnormalities, as well as planning and monitoring therapy.