FDA Radiology AI Devices

The CT 5300 by Philips Healthcare is an advanced computed tomography system designed to produce detailed cross-sectional images of the head, body, cardiac and vascular structures. It supports various CT applications including diagnostic and low-dose lung cancer screening. The system uses AI-enhanced image reconstruction to provide high quality images at reduced radiation dose, helping clinicians detect and analyze anatomical features and abnormalities.

True Enhance DL is a deep learning-based software from GE Healthcare Japan Corporation that enhances contrast in standard 120 kVp CT images of the body, making details clearer without requiring changes to acquisition parameters. It is intended to assist clinicians by providing improved image contrast to aid diagnosis and is suitable for patients of all ages.

The Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System is a multi-slice CT scanner that uses advanced AI-based deep learning reconstruction algorithms to improve image quality by enhancing spatial resolution and reducing noise. It can capture detailed cross-sectional volumes of the whole body including organs like the brain, heart, and pancreas in a single rotation, assisting physicians in diagnostic and specialized studies.

The NAEOTOM Alpha is a dual-source computed tomography (CT) scanner developed by Siemens Medical Solutions. It uses advanced photon-counting detector technology and incorporates AI-driven image reconstruction and post-processing software to produce highly detailed cross-sectional images. This device assists trained clinicians in diagnosing and treating patients, including applications like low-dose lung cancer screening in high-risk populations. It features enhanced workflow tools, integrated needle guidance for interventions, and supports sophisticated quantitative imaging techniques.

The SOMATOM go. Platform and SOMATOM X. Platform CT scanners, produced by Siemens Medical Solutions USA, Inc., are advanced computed tomography systems designed to generate detailed cross-sectional images of patients. These devices aid healthcare professionals in diagnosis, treatment planning, and radiation therapy across a variety of clinical scenarios, including lung cancer screening. The systems feature a fan-beam CT technology, sophisticated software for image reconstruction and optional AI-assisted workflow enhancements such as automated needle detection for intervention procedures, and innovative camera-based patient positioning workflows. They improve clinical accuracy and efficiency while ensuring patient comfort and safety.

The Revolution Ascend Sliding is a CT X-ray system designed to generate detailed cross-sectional images of the body, including head, whole body, cardiac, and vascular areas. Uniquely, it features a gantry mounted on a transporter allowing linear movement on rails, improving patient workflow by enabling imaging and treatment procedures in the same room without moving the patient. It supports a range of acquisition modes and image processing features to aid clinicians in diagnosis and therapy monitoring.

The Aquilion Serve SP (TSX-307B/1) V1.3 is a multi-slice helical CT scanner that acquires and displays whole-body cross-sectional imaging volumes. It includes an AI-based noise reduction algorithm called AiCE (Advanced Intelligent Clear-IQ Engine) that enhances image quality by reducing noise using deep learning techniques. This helps clinicians obtain clearer diagnostic images for various applications including abdomen, pelvis, lung, cardiac, extremities, head, and inner ear imaging.

The NeuViz 128 Multi-Slice CT Scanner System by Neusoft Medical Systems is a CT scanner designed for whole body imaging, producing cross-sectional images to help clinicians diagnose various medical conditions. It incorporates advanced AI-powered reconstruction methods to reduce noise and enhance image quality, potentially lowering radiation dose for patients while improving diagnostic capabilities.

Aquilion Serve (TSX-307A/1) V1.3 is a whole-body multi-slice helical CT scanner that captures detailed cross-sectional volume images including the head. It incorporates AiCE, an AI-powered noise reduction algorithm using deep convolutional neural networks to improve image quality and reduce noise. This helps clinicians obtain clearer images for specialized studies across multiple anatomical regions, aiding diagnosis and treatment planning while potentially reducing radiation dose.

Deep Learning Image Reconstruction by GE Healthcare Japan Corporation is a deep learning based software integrated into CT scanners to reconstruct high-quality cross-sectional images of the head, whole body, cardiac, and vascular systems. It uses a trained deep neural network to reduce image noise and artifacts while maintaining spatial resolution, aiding clinicians in obtaining clearer diagnostic images with routine CT throughput.