FDA Radiology AI Devices

ProstatID is an AI software tool designed to assist radiologists by analyzing prostate MRI scans to identify and assess suspicious lesions that may indicate prostate cancer. It processes MRI images and provides detection overlays, lesion likelihood scores, 3D renderings, and a summary report to support diagnostic decisions for high-risk screening or diagnostic imaging.

The MAGNETOM Free.Max and MAGNETOM Free.Star are advanced magnetic resonance imaging (MRI) systems designed by Siemens. These devices produce detailed cross-sectional images of the body to help clinicians visualize internal structures and diagnose various conditions. Featuring new software and hardware enhancements, they provide improved imaging workflows, patient comfort with different bore sizes, and automated shoulder examination support, aiding physicians in accurate diagnosis and patient management.

CoLumbo is a medical imaging AI software tool designed to assist radiologists and spine surgeons by automatically segmenting and measuring lumbar spine features from MRI images. It highlights out-of-range measurements and generates reports for review and approval by clinicians, improving the efficiency and consistency of lumbar spine evaluation, but does not provide diagnosis.

The Swoop Portable MR Imaging System is a bedside portable MRI device designed for producing images of the internal structure of the head when full diagnostic exams are not feasible. It uses advanced AI-based image reconstruction algorithms to enhance image quality with reduced noise and blurring, aiding clinicians in diagnosis at the point of care, such as emergency rooms or critical care units.

AIR Recon DL is a deep learning-based software feature for GE Healthcare MRI systems that improves image quality by reducing noise and ringing artifacts in MRI images. It helps clinicians by enabling shorter scan times without losing image clarity, thus improving patient comfort and diagnostic accuracy across multiple anatomies and MR field strengths.

SwiftMR is a software device that automatically enhances MRI images by reducing noise and increasing image sharpness using deep learning algorithms. It supports brain, spine, and musculoskeletal MRI images and integrates with existing PACS systems to improve diagnostic image quality without interrupting clinical workflow.

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.

Quantib Prostate is an AI-powered image post-processing software designed to assist medical professionals in analyzing prostate MRI scans. It provides tools for visualization, semi-automatic segmentation of prostate anatomy and lesions, volume computations, and PI-RADS scoring support to facilitate the interpretation of prostate MR studies, aiding clinical decision-making.

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.