FDA Radiology AI Devices

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.

BriefCase-Triage is an AI-powered software designed to assist hospital networks and trained radiologists in identifying suspected pulmonary embolism cases from CT pulmonary angiography (CTPA) images. The software analyzes images in parallel with standard interpretation, flags potential positive findings, and notifies clinicians with compressed preview images for triage purposes, helping prioritize urgent cases and reduce turnaround times without replacing standard diagnostic workflows.

Hyper Insight - ICH is an AI-powered clinical software tool that analyzes brain CT scans to detect suspected intracranial hemorrhage. It provides timely notifications to medical specialists to prioritize patient care, helping clinicians triage potential emergencies more efficiently. The software serves as a supplementary notification aid rather than a definitive diagnostic tool, enhancing workflow efficiency and supporting faster treatment decisions.

SMART Bun-Yo-Matic CT is an AI-based software tool that helps orthopedic healthcare professionals by automatically segmenting foot and ankle bones from CT images, creating 3D anatomical models, measuring structures, and providing surgical planning visualizations. This supports diagnosis and treatment planning, especially for conditions like hallux valgus, through detailed, interactive reports and templates.

Relu Creator is a software program used by dental specialists to manage and analyze dental and craniomaxillofacial medical images. It helps with 3D modeling of patient anatomy through image segmentation and registration, supporting preoperative planning and treatment in dental disciplines like orthodontics and implantology. The software enhances and displays images from multiple sources and stores them for easy access, assisting clinicians in planning dental treatments more effectively.

The Cardiac CT Function Software Application by Circle Cardiovascular Imaging is a software tool that assists medical professionals in analyzing cardiac function from multi-phase, multi-slice cardiovascular CT angiography images. It uses AI to segment cardiac structures and compute key function metrics such as volume and ejection fraction, helping clinicians evaluate heart function more accurately and efficiently.

CINA-VCF is an AI-powered software device designed to analyze chest and abdominal CT scans in patients aged 50 and above to identify suspected vertebral compression fractures. It operates alongside standard imaging workflows to prioritize and notify clinicians of potentially positive cases, helping improve triage speed and efficiency without altering original images or serving as a diagnostic tool itself.

uOmnispace.CT is a comprehensive medical image management and processing software mainly for CT images, developed by Shanghai United Imaging Healthcare. It provides various AI-driven analysis tools including lung nodule detection, brain perfusion analysis, cardiovascular and liver evaluations, and more. This software supports clinical interpretation, visualization, and quantitative assessment, helping clinicians diagnose and plan treatments more efficiently across multiple organ systems.

Heuron ICH is an artificial intelligence software that assists medical specialists by analyzing non-contrast head CT images to identify suspected cases of intracranial hemorrhage. It provides notifications and compressed preview images to help prioritize patient care and streamline workflow, without modifying the original images or serving as a diagnostic device.

BriefCase-Quantification is an AI-powered software that analyzes CT scans of the abdominal aorta to measure its maximum diameter. It helps trained medical specialists by providing preliminary diameter measurements to assist with evaluating normal and aneurysmal abdominal aortas, improving the efficiency of radiological assessments. The software is cloud-based, processes images from DICOM format, and integrates output with PACS for clinician review.