FDA Radiology AI Devices

Second Opinion® CS is a computer-aided detection software designed to help dental health professionals detect and segment caries in radiographs of permanent teeth. Using AI and machine learning, it highlights potential caries lesions and provides detailed analysis on their overlap with tooth structures, improving diagnostic accuracy and assisting clinicians in reviewing dental images.

Aurora is a medical imaging system that combines nuclear medicine (SPECT) and CT imaging to help healthcare professionals detect and evaluate diseases including cardiovascular, neurological disorders, and cancer. It provides enhanced imaging through various scanning modes, real-time processing features including deep-learning based automatic kidney segmentation, and supports therapy planning and monitoring.

Viz Subdural+ is an AI-powered software that automatically analyzes head CT scans to measure subdural collections and midline shift. It helps clinicians by providing automated volume and width measurements of subdural collections, improving efficiency and accuracy in brain injury assessment.

The EXTRON series (EXTRON 3, EXTRON 5, EXTRON 7) are mobile fluoroscopic X-ray systems that provide high-quality, real-time X-ray images to support clinicians during emergency injury treatment, orthopedic surgery, neurosurgery, and other interventions. The system includes advanced image processing capabilities and enables saving and transferring images to hospital PACS, improving diagnosis and workflow in surgical settings.

Cirrus Resting State fMRI Software is a medical imaging software that processes resting state functional MRI data to generate brain maps showing motor, language, and vision networks. These maps assist clinicians such as surgeons and radiologists in visualizing functional areas of the brain non-invasively, aiding in pre-surgical planning and clinical decision-making.

UroNav 4 is a medical image processing and navigation system that helps clinicians plan and guide biopsy and soft tissue ablation procedures, especially for the prostate gland. It fuses and registers 2D and 3D ultrasound images with other imaging modalities like MRI to provide real-time image guidance using electromagnetic tracking. This enhances precision in navigating interventional instruments, improving clinical outcomes in minimally invasive procedures.

TechLive is a software application designed to enable healthcare professionals to remotely access and control medical imaging devices in real-time for image acquisition, assistance, review, and training. It supports multiple imaging modalities and fosters collaboration among clinical staff across different locations, improving operational support and training without being intended for diagnostic use.

Sonic DL is a software feature for GE HealthCare MR systems that uses deep learning algorithms to reconstruct MR images from highly under-sampled data, enabling faster image acquisition and maintaining diagnostic quality. It supports multiple MR field strengths and is used across various anatomies, including cardiac, brain, spine, musculoskeletal, abdomen, pelvis, and breast imaging, helping clinicians obtain high-quality MR images more quickly.

BrightHeart View Classifier is a cloud-based AI-powered software designed to analyze 2D fetal ultrasound images and video clips to automatically identify and classify standard fetal heart views. It assists trained healthcare professionals in acquiring and interpreting fetal heart ultrasound exams in the second and third trimesters by providing annotated outputs and validating whether scanning protocols are met, improving diagnostic workflow and consistency.

TraumaCad Neo (1.1) is software that helps surgeons plan and evaluate orthopedic procedures by using X-ray images. It overlays measurements and prosthesis templates to assist in surgical planning and postoperative assessment, including automated analysis of hip arthroplasty outcomes using AI. This streamlines workflow and supports clinical decisions prior to and after surgery.