FDA Radiology AI Devices

ANKYRAS is a medical software device designed to assist clinicians in visualizing cerebral blood vessels and simulating the placement and sizing of neurointerventional braided endovascular devices such as flow diverters. It helps physicians plan neurovascular interventions by allowing 3D modeling based on imaging data from 3D rotational angiography, offering features like segmentation, centerline generation, and device simulation to improve pre-surgical planning and patient outcomes.

LUMYS (V1) is a medical software platform designed to assist clinicians in pre-surgical planning by providing 3D visualization and interactive image segmentation of CT scan data. Using Microsoft HoloLens 2 for a mixed reality view, it enables surgeons and remote collaborators to annotate and interact with medical images in real time during procedures, improving communication and surgical precision, but it is not intended for primary diagnosis.

VersaViewer is a medical image management and processing system software developed by GE Medical Systems SCS. It supports 2D, 3D, and 4D medical images from multiple modalities and provides customizable layouts for multimodality review. It offers measurement, annotation, segmentation tools, and advanced visualization options to assist trained healthcare professionals in diagnostic workflows. The software includes an optional One View feature for automated multi-organ segmentation using deep learning, enhancing radiologists' efficiency in interpreting spectral CT exams. It is intended to assist physicians in diagnosis, though physicians retain final decision-making responsibility.

LARALAB is an AI-powered medical imaging software that helps cardiologists, radiologists, and heart surgeons visualize, assess, and measure cardiovascular structures from medical images. It automates segmentation and measurements to assist in preprocedural planning and postprocedural review, improving workflow efficiency and accuracy in cardiovascular care.

MySegmenter (v2.0.0) is a medical imaging software that converts CT and MRI scans into 3D anatomical models for surgical planning and educational use, specifically in orthopedic and craniomaxillofacial cases. It helps clinicians visualize and prepare for surgeries by creating accurate, patient-specific 3D models, though it is not intended for use in the operating room.

Clarius Prostate AI is an AI-powered ultrasound software tool integrated into the Clarius Ultrasound Scanner system. It assists qualified healthcare professionals by automatically detecting, segmenting, and measuring prostate volume in ultrasound images, helping to streamline clinical workflow and improve prostate assessment accuracy while allowing manual adjustments. It is intended for adult male patients and supports prostate imaging with curvilinear and endo-cavitary scanners.

OTOPLAN is software that helps otologists and neurotologists visualize, segment, and analyze medical images such as CT and MRI scans to assist in planning and assessing ear-related surgical procedures like cochlear implantation. It provides tools for 3D reconstruction, electrode visualization, and image fusion, enhancing surgical planning accuracy and patient outcomes.

GBrain MRI is a software tool that automatically segments, quantifies, and reports the volume of signal hyperintensities in brain MR FLAIR images. It helps radiologists by providing quantitative measurements to support the evaluation of brain MRI scans, enhancing clinical assessment without replacing the physician's judgment.

Vitrea CT VScore is a software application designed to aid medical professionals in visualizing, segmenting, and quantifying calcified lesions in ECG-gated cardiac CT images of patients aged 30 years or older. It provides calcium scoring and generates detailed reports to assist clinicians in cardiac imaging assessment.

QFR (3.0) is a software device that processes X-ray angiogram images to provide quantitative analysis of coronary vessels. It uses deep learning and 3D reconstruction from angiographic images to measure vessel dimensions and quantify pressure drops, aiding cardiologists in evaluating coronary artery disease and supporting treatment decisions.