FDA Radiology AI Devices

MAGNETOM Avanto fit and MAGNETOM Skyra fit are advanced MRI systems designed by Siemens that provide high-quality magnetic resonance imaging. These devices produce detailed cross-sectional images as well as spectroscopic data of the head, body, and extremities, helping physicians diagnose a variety of conditions and support imaging during interventional procedures with MR compatible devices.

SwiftMR is a software tool that automatically enhances MRI images by reducing noise and increasing sharpness using deep learning techniques. It integrates with medical imaging systems (PACS or MRI machines) to improve image quality, aiding radiologists and clinicians in better interpreting MRI scans.

The Clarius Ultrasound Scanner is a portable, software-controlled ultrasound device that wirelessly connects to iOS or Android devices to provide real-time, high-resolution diagnostic ultrasound images across many clinical applications such as cardiac, abdominal, pediatric, and musculoskeletal imaging. It helps healthcare professionals by offering dual-array transducer functionality in a single device, enhancing convenience and efficiency during ultrasound exams.

The Cartesion Prime (PCD-1000A/3) V10.15 is a PET/CT emission computed tomography system designed for diagnostic imaging. It helps clinicians by producing high-quality fused metabolic and anatomical images through PET and CT scans, improved by AI-driven noise reduction and motion correction. This aids in the evaluation, diagnosis, and treatment planning of various diseases such as cancer, cardiovascular and neurological disorders.

The MAGNETOM Viato.Mobile by Siemens is a 1.5 Tesla mobile MRI system designed to be relocated to different locations where imaging services are needed. It produces high-quality MR images of the head, body, and extremities in multiple planes and can also be used during interventional procedures. This helps clinicians diagnose a variety of conditions by providing detailed internal anatomical and functional imaging.

Spine Auto Views is a software tool that automatically processes CT images of the spine to create anatomically focused reformatted views and labels vertebrae and disc spaces, facilitating quick and consistent review for clinicians. It utilizes deep learning algorithms to generate multiple reformatted image planes without user interaction and exports the results automatically for radiologist reading.

The EPIQ Series Diagnostic Ultrasound System by Philips Ultrasound LLC is a diagnostic ultrasound imaging device used to visualize and analyze fluid flow in the human body. It supports a wide range of clinical applications including abdominal, cardiac, vascular, musculoskeletal, and ophthalmic imaging, enhancing clinicians' ability to diagnose and guide treatment with high-resolution imaging and fluid flow analysis.

SubtleMR (2.3.x) is an AI-powered software that improves MRI images by reducing noise or enhancing sharpness. It supports MRI scans of various body regions such as head, spine, abdomen, and more. This helps clinicians obtain clearer images, potentially improving diagnostic accuracy without additional scans or equipment.

Precision DL by GE Healthcare is a deep learning software designed to improve the quality of non-Time-of-Flight PET images used in clinical oncology. It enhances image contrast and reduces noise, helping clinicians obtain clearer PET scans to better detect and evaluate cancer, ultimately supporting improved patient care.

Ezra Flash is a software tool that uses AI (convolutional neural networks) to enhance brain MRI images by reducing noise. It supports 3-Tesla Siemens and GE MRI scanners for specific sequences, providing clearer images to assist radiologists in diagnosis without altering the original images.