FDA Radiology AI Devices

The Ingenia series MR Systems by Philips Medical Systems Nederland B.V. are advanced MRI devices that produce detailed cross-sectional images and spectra of the head, body, and extremities. Utilizing strong magnetic fields and radio signals, these systems aid physicians in diagnosing diseases, planning treatments, and guiding minimally invasive procedures by providing high-quality images. The new Precise Image software feature enhances image quality by employing deep learning to improve sharpness and reduce noise and artifacts, facilitating better clinical assessment.

MAGNETOM Amira and MAGNETOM Sempra are magnetic resonance imaging (MRI) systems designed to produce detailed images and spectra of the head, body, and extremities. They include advanced AI-powered image reconstruction features such as Deep Resolve Boost and Deep Resolve Sharp, which enhance image quality and sharpness. These systems assist clinicians by providing faster, higher-quality images to improve diagnosis and guide interventions.

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.

BoneMRI v1.6 is an AI-powered software that enhances MRI images to improve visualization of bone structures in the pelvic and lumbar spine regions. It uses advanced algorithms, including convolutional neural networks, to generate 3D images with enhanced bone contrast. This allows clinicians such as radiologists and orthopedic surgeons to better assess bone morphology and tissue density without the need for CT scans, improving diagnostic capabilities in these regions.

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.

MR Diffusion Perfusion Mismatch V1.0 by Olea Medical is an AI-powered software tool that automatically processes MR Diffusion and Perfusion imaging data to compute parametric maps, extract volume metrics, and calculate mismatch volumes. It assists radiologists and surgeons by providing quantitative imaging data that supports clinical decision-making. The software integrates with medical image platforms to streamline workflow without altering the original images and is intended to be used alongside other clinical information, not as a standalone diagnostic tool.

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.

BrainInsight is an automated software that processes low-field MRI brain images to provide automatic labeling, spatial measurement, and volumetric quantification of brain structures. It produces annotated and segmented brain images with color overlays and detailed reports, helping clinicians assess brain anatomy and abnormalities efficiently, particularly using low-field MRIs.

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.