FDA Radiology AI Devices

OptimMRI is a software tool that helps medical professionals analyze pre-operative brain MRI images by generating 3D annotated models. It supports neurosurgical planning by localizing key brain regions, helping doctors visualize and plan treatments more precisely.

uOmnispace is a medical image post-processing software solution that supports viewing, manipulation, annotation, and communication of various medical images from multiple modalities including CT, MRI, PET and DR. It includes AI-based segmentation tools like rib segmentation, and enables remote multi-user access and integration with medical imaging systems. It helps clinicians efficiently analyze and report on diagnostic images.

Axial3D Insight is a cloud-based service that processes medical imaging DICOM data to create detailed 3D digital files or physical 3D printed models. These models assist clinicians in treatment planning and diagnosis across orthopedic trauma, maxillofacial, and cardiovascular applications, improving surgical preparation and outcomes.

Bladder AI is a software designed to assist healthcare providers in measuring bladder volume from ultrasound images using machine learning. It supports image-based assessment, landmark placement, and report generation for patients aged 2 years and older, improving workflow efficiency and accuracy in bladder volume quantification.

DeepCatch is software that analyzes whole-body CT scans to automatically identify and measure various anatomical structures like skin, muscle, fat, internal organs, and the central nervous system. It produces 3D models and quantitative data to help doctors better understand the patient's body composition and anatomy, aiding clinical decisions by providing accurate volume and proportion measurements.

FEops HEARTguide™ ALPACA is an AI-enabled medical imaging software system that helps clinicians visualize and measure detailed heart and vessel structures from CT images. It aids in planning minimally invasive heart procedures by providing automated segmentation, 3D visualization, measuring tools, and reporting. This software supports better procedural decisions by combining anatomical insights with clinical evaluation.

The SIS System is a software tool that uses advanced machine learning and image processing to help surgeons, neurologists, and radiologists visualize critical brain structures in 3D. It assists in planning neurological procedures such as Deep Brain Stimulation by creating detailed anatomical models from MRI images and localizing implanted leads on post-operative CT images, improving accuracy and surgical outcomes.

Ceevra Reveal 3 is a software medical device designed for processing, reviewing, and analyzing 3D images created from CT and MR scans. It helps clinicians with preoperative surgical planning and intraoperative image display, including interacting with 3D visualizations using mobile or desktop viewers, and even VR headsets. By using AI-driven algorithms, it generates preliminary segmentations of normal anatomical structures to assist healthcare professionals in their clinical decisions for adult patients.

Formus Hip is a preoperative planning software designed to assist orthopedic surgeons by automatically generating 3D models of the hip from CT scans and overlaying digital representations of hip implants. It uses AI algorithms for image segmentation and statistical shape modeling, helping clinicians plan hip replacement surgeries more effectively by customizing implant fitting interactively and producing printable surgical plans.

MPXA-2000 is a software tool intended for cardiologists and radiologists to automatically analyze X-ray angiographic images of the coronary arteries. It uses deep learning and computer vision algorithms to segment blood vessels, classify vessel types, quantify vessel dimensions, and support clinical decisions related to coronary artery disease. The software provides validated, reproducible quantitative results to aid in diagnosis and treatment evaluation, with results available for review and export.