FDA Radiology AI Devices

The Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR is a 3 Tesla MRI system produced by Canon Medical Systems Corporation. It provides high-quality cross-sectional images of anatomical structures in the head or body, including advanced imaging techniques such as non-contrast enhanced MRA and diffusion imaging. The AiCE Reconstruction Processing Unit uses AI to enhance and speed up the image reconstruction process, helping clinicians obtain clear and detailed MR images for diagnosis.

CoLumbo is a software tool that helps radiologists and spine surgeons analyze MRI images of the lumbar spine by automatically segmenting anatomical features and measuring spine structures. It identifies out-of-range measurements and assists users in documenting findings, streamlining the review and reporting process without making any medical diagnosis.

OptimMRI (v2) is a software application that processes MRI brain images to generate detailed 3D annotated models highlighting specific brain regions. It helps clinicians in planning neurosurgical procedures by localizing critical brain nuclei, thus supporting accurate functional planning and improving surgical outcomes.

The i2Contour by MRIMath LLC is a web-based AI-assisted software designed to semi-automatically segment and quantify glioblastoma tumors from MRI scans. It helps trained medical professionals by providing initial tumor contours which can be reviewed and manually adjusted, enabling accurate tumor volume assessments for patients with pathologically confirmed glioblastoma. This facilitates monitoring tumor progression or treatment response but is not intended for primary diagnosis.

MICSI-RMT is a software medical device designed to improve head MRI images by reducing noise, enhancing image quality to assist radiologists. It processes functional and diffusion MRI images without a user interface, outputting enhanced images for better visualization of brain structures and activation maps, aiding in clinical MRI interpretation.

The Swoop Portable MR Imaging System by Hyperfine, Inc. is a portable ultra-low field MRI device designed to image the internal structure of the head. It provides physicians with useful diagnostic images in environments where full diagnostic examination is not practical. The system uses deep learning reconstruction algorithms to improve image quality and is intended for use at the point of care, such as emergency rooms and intensive care units, enhancing access to MRI imaging in diverse clinical settings.

SubtleSYNTH (1.x) is an AI-based software that synthesizes STIR contrast images from T1- and T2-weighted spine MRI sequences. It uses a convolutional neural network to generate synthetic images that can be reviewed alongside traditional MRI scans, helping radiologists by providing additional image contrast information without additional scanning time or patient burden.

Medihub Prostate is a semi-automatic image processing software designed for analyzing prostate MR images. It uses AI to outline the prostate region semi-automatically and supports radiologists and urologists in reviewing MR data. The software requires user editing and confirmation, enhancing the accuracy of prostate volume measurements and analysis, aiding clinical decision-making without replacing the expert's judgment.

The SIS System by Surgical Information Sciences, Inc. is an advanced software tool that assists clinicians, including surgeons, neurologists, and radiologists, by providing detailed visualization and 3D models of specific brain structures. It uses machine learning models trained on high-resolution MR images to aid in planning and guiding deep brain stimulation surgeries and other neurological procedures, helping to precisely locate key brain areas and implanted leads for improved surgical outcomes.

The ECHELON Synergy V10.0 MRI system by Fujifilm Healthcare Americas Corporation is an advanced magnetic resonance imaging device that produces detailed cross-sectional images of the body using non-ionizing magnetic fields. It helps physicians diagnose various conditions by providing high-quality images reflecting tissue properties such as proton density and relaxation times. This system includes updated software features with AI-powered image processing to improve image quality and workflow efficiency, benefiting both clinicians and patients.