FDA Radiology AI Devices

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.

AI-Rad Companion Brain MR is software that assists clinicians by automatically analyzing brain MRI scans. It segments various brain structures, quantifies their volumes, and highlights white matter hyperintensities, comparing results to normal data. This helps radiologists make more accurate and efficient evaluations of brain health.

Customize is a software tool designed to assist physicians in planning shoulder arthroplasties by visualizing, modifying, and validating 3D models generated from CT scans. It helps communicate treatment options, segments CT data, and manages cases and timelines, aiding clinicians in surgical preparation and decision-making.

Arterys MICA is a cloud-based medical imaging software that helps healthcare professionals view, process, and analyze medical images from CT and MRI scans. It includes AI modules that assist in cardiac and oncology evaluations by automating image quantification and lesion assessments, supporting clinicians in their diagnostic workflows.

LVivo Seamless is an AI-powered software application that analyzes ultrasound (echocardiogram) images to automatically detect heart structures, measure ejection fraction (EF), and calculate global longitudinal strain (GLS), aiding clinicians in assessing cardiac function efficiently and accurately. It runs offline on a server in healthcare settings, accepts DICOM-format ultrasound clips from various vendors, and sends results to PACS for professional review.

OnQ Neuro is an automated software device designed to analyze neurological MRI images, specifically for brain tumors. It performs automatic segmentation and quantification of tumor volumes and diffusion-weighted imaging data, helping clinicians assess tumor progression and treatment response more efficiently by providing quantitative and graphical image data that can be integrated into clinical workflows.

breastscape v1.0 is an advanced software tool used with Olea Sphere 3.0 to assist breast imaging physicians and MRI technologists in analyzing breast MRI data. It provides visualization, semi-automatic lesion segmentation, kinetic curve analysis, and planning assistance for MR-guided breast biopsy procedures, helping clinicians detect and characterize breast lesions and plan interventions more effectively.

qER-Quant is an AI-powered software that processes non-contrast head CT scans to automatically identify and quantify key brain structures such as intracranial hyperdensities, lateral ventricles, and midline shift. It helps clinicians by providing volumetric data and visual overlays to aid in diagnosis and monitoring brain conditions over time.

The syngo.via MI WorkFlows, including Scenium and syngo MBF, is a software suite from Siemens designed to assist healthcare professionals by providing advanced image processing, visualization, and quantitative analysis for multiple medical imaging modalities such as PET, CT, MRI, and SPECT. It supports disease management in oncology, cardiology, neurology, and organ function, helping clinicians interpret complex images and plan treatments more effectively.

Imbio RV/LV Software is an AI-powered medical imaging tool that automatically measures the diameters of the right and left ventricles of the heart from CT pulmonary angiography scans. It provides annotated images and reports to assist physicians in evaluating heart function, supporting clinical decision-making as part of cardiac assessment workflows.