FDA Radiology AI Devices

The syngo.CT CaScoring software by Siemens is used to analyze non-contrast cardiac CT scans to detect and evaluate calcified lesions in coronary arteries. It calculates scores like the Agatston score, mass, and volume scores for different coronary arteries, helping physicians assess coronary artery disease and generate detailed reports to support patient management.

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.

Saige-Dx is an AI-based software that analyzes digital breast tomosynthesis mammograms to detect suspicious soft tissue lesions and calcifications that may indicate cancer. It provides radiologists with a suspicion level for each finding and the entire case, helping improve detection accuracy and reduce reading time during breast cancer screening.

The Versana Balance by GE Medical Systems is a general-purpose diagnostic ultrasound system intended for use by trained healthcare professionals. It offers various imaging modes including B-mode, Doppler, 3D/4D imaging, and elastography. The device assists clinicians by providing high-quality ultrasound images and includes AI features such as Whizz Label for anatomy identification, helping in image interpretation and workflow efficiency. It is designed for use in hospitals and clinics across a broad range of clinical applications including abdominal, cardiac, obstetrics, gynecology, vascular and musculoskeletal imaging.

Overjet Caries Assist is an AI-powered software that helps dentists detect and outline tooth decay on bitewing dental X-ray images. It automatically identifies possible caries areas, providing visual annotations to assist dentists in diagnosis and treatment planning. This tool supports dental professionals by improving caries detection sensitivity while allowing them to review and adjust annotations, enhancing diagnostic accuracy without replacing clinical judgment.

Segment 3DPrint is a medical software developed by Medviso AB that helps clinicians review and segment images from medical scanners to generate detailed 3D models. These models assist doctors with visualization, measuring, and treatment planning, particularly in orthopaedic, maxillofacial, and cardiovascular fields. The software also supports creating physical 3D printed replicas from these models, enhancing clinical workflows and patient care.

MVision AI Segmentation is a software device designed to automatically create segmentation templates of anatomical regions on CT images to assist clinicians in radiation therapy treatment planning. It uses machine learning-based algorithms to generate initial contours for multiple anatomical sites, which clinicians can review and modify before use, helping to save time and improve efficiency in clinical workflows.

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.