FDA Radiology AI Devices

The uMI Panorama is a diagnostic imaging system that combines PET and CT imaging modalities to provide detailed metabolic and anatomical information. It assists clinicians in detecting, diagnosing, staging, and managing diseases, inflammation, infection, and disorders in multiple clinical fields. This system can also independently function as a CT scanner for lung cancer screening and delivers enhanced image reconstruction through AI algorithms, improving image quality and diagnostic accuracy.

The Aquilion Precision (TSX-304A/4) V10.14 with AiCE is an advanced whole-body CT scanner that leverages AI through deep convolutional neural networks to reduce image noise and improve image quality. It also uses an iterative reconstruction algorithm to reduce radiation dose while enhancing spatial resolution. This helps clinicians obtain clearer and more detailed images to support diagnosis and treatment planning across various body regions, including abdomen, chest, brain, and extremities.

The Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i is a whole-body multi-slice helical CT scanner enhanced with AiCE, an AI-based noise reduction algorithm using deep convolutional neural networks. It improves image quality and reduces noise for abdomen, pelvis, lung, cardiac, extremities, head, and inner ear scans, helping clinicians obtain clearer diagnostic images faster and with potentially reduced radiation dose.

The Swoop Portable MR Imaging System by Hyperfine is a bedside portable MRI device designed to produce images of the internal structure of the head. It uses magnetic resonance imaging with advanced image reconstruction algorithms that include deep learning to enhance image quality by reducing noise and blurring. This helps clinicians obtain diagnostic images even when full diagnostic examination is not practical, aiding diagnosis at the point of care in facilities such as emergency and critical care units.

The uCT ATLAS Astound with uWS-CT-Dual Energy Analysis is an advanced CT scanner designed to produce cross-sectional images of various body regions, including head, whole body, cardiac, and vascular areas. It integrates deep learning for image reconstruction to enhance image quality and reduce noise, and includes software for dual energy analysis to differentiate tissue types based on their chemical composition. This aids clinicians in lung cancer screening and detailed anatomical evaluation, supporting early diagnosis and treatment.

The uMR 680 is a 1.5 Tesla superconducting magnetic resonance imaging (MRI) system designed to produce diagnostic-quality images of the head, body, and extremities. It includes a deep-learning based image processing algorithm called DeepRecon for image denoising and super-resolution, enhancing image quality and assisting clinicians in diagnosis.

The SIGNA Victor is a 1.5 Tesla whole body MRI scanner designed to provide high-resolution diagnostic images quickly and with a high signal-to-noise ratio. It produces images in multiple planes and supports imaging of the entire body, including brain, spine, joints, heart, abdomen, and more, aiding clinicians in diagnosing a variety of conditions.

The MR 5300 and MR 7700 R11 MR Systems by Philips are advanced magnetic resonance imaging (MRI) devices that provide high-quality images of the internal structures of the head, body, or extremities. These systems help clinicians by enabling detailed visualization, which supports diagnosis, therapy planning, and interventional procedures. The devices incorporate updated software (R11) and minor hardware enhancements, including AI-powered SmartSpeed features that improve image acquisition and reconstruction, facilitating faster and more accurate MRI scans.

The Philips CT 3500 is a computed tomography X-ray system designed to produce detailed images of the head, whole body, cardiac, and vascular regions. It supports diagnostic imaging and low dose lung cancer screening using advanced imaging features and includes AI-based image reconstruction for improved image quality at reduced dose, helping clinicians with early detection and diagnosis.

The Swoop Portable MR Imaging System by Hyperfine is a bedside MRI device that allows clinicians to capture magnetic resonance images of the head without moving the patient. It utilizes advanced deep learning-based image reconstruction to improve image quality, reducing noise and blurring. This portable device helps provide timely diagnostic information in critical care settings where traditional MRI is difficult.