FDA Radiology AI Devices

Imbio PHA (4.0.0) is a medical image processing software designed to measure the maximal diameters of the heart's right and left ventricles, the main pulmonary artery, and the ascending aorta from CT pulmonary angiography scans. It uses artificial intelligence to identify and measure these structures, providing annotated images and summary reports to assist clinicians in evaluating cardiovascular health.

NeuroQuant is an automated software device designed to help clinicians by providing automatic labeling, visualization, and volumetric measurement of brain structures and lesions from MRI scans. It enhances clinical workflow by delivering segmented images and morphometric reports that can be reviewed and compared to normative data, aiding in diagnosis and monitoring of neurological conditions.

qCT LN Quant is a software tool that helps radiologists track, assess, and quantify lung nodules seen in CT scans. It provides volumetric and diameter measurements of user-selected nodules, with 2D and 3D visualizations, and uses AI algorithms to assist in characterizing nodules including measurements like volume doubling time and density. It supports clinical decision-making with integrated risk calculators based on established lung nodule malignancy and management guidelines.

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.

CardIQ Suite is a non-invasive software tool that analyses 2D and 3D CT cardiac images to assist clinicians in visualizing and measuring heart structures and vessels. It provides calcium scoring to evaluate calcified plaques and uses deep learning algorithms to automate segmentation and labeling of heart and coronary arteries, improving diagnostic workflow for cardiovascular diseases.

RUS by Hutom Inc. is a medical imaging software designed to aid healthcare professionals in reading, interpreting, and planning treatment based on iodine contrast-enhanced abdominal CT scans. The software provides basic imaging tools, 3D modeling, and segmentation of anatomical structures, including organs and vessels, enhancing surgical planning and diagnosis. It incorporates AI-based machine learning models to improve accuracy in organ segmentation, vessel detection, and pneumoperitoneum analysis, supporting clinicians in patient management decisions.

Acorn 3D Software is an advanced medical imaging software that processes CT and CTA scans to visualize, segment, and create detailed 3D digital models of musculoskeletal and craniomaxillofacial anatomy, including spine regions. It offers machine learning-based automatic segmentation for certain vertebrae and semi-automatic/manual tools for other bones. Clinicians can use these digital models for measurement, treatment planning, and can also produce physical 3D printed replicas for diagnostic purposes, enhancing surgical planning and patient care.

The V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System by Samsung Medison Co., Ltd. is a general-purpose diagnostic ultrasound system that acquires ultrasound data and displays it in multiple modes including 2D, Doppler, and 3D/4D. It helps healthcare professionals with imaging and fluid flow analysis across many clinical applications such as fetal, cardiac, abdominal, and musculoskeletal imaging. The system includes AI-based features such as NerveTrack for nerve segmentation, enhancing diagnostic capabilities.