FDA Radiology AI Devices

Viz LVO is an AI-based software tool designed for hospital networks and clinicians to detect and notify specialists about suspected large vessel occlusions in brain CT angiograms. It facilitates rapid communication and prioritization of cases to improve stroke patient management, providing image previews via a mobile app for informational use to assist timely specialist review.

AI-Rad Companion (Musculoskeletal) is an AI-powered software that analyzes previously acquired CT images to assist radiologists and physicians in evaluating musculoskeletal diseases. It segments, labels vertebrae, measures vertebral heights, and computes mean Hounsfield values to provide detailed quantitative and qualitative analysis, improving assessment and workflow efficiency for clinicians.

Spine CAMP™ is a fully-automated software that analyzes X-ray images of the spine to measure and assess spinal parameters, such as alignment, stability, and motion. It helps healthcare professionals by providing quantitative metrics and visualizations, improving clinical decision-making regarding spinal health and treatments.

AI-Rad Companion Organs RT is a software product by Siemens that uses deep learning to automatically contour organs at risk on CT imaging data. The output contours help radiation oncologists plan external beam radiation therapy by providing accurate anatomical structures for treatment planning. The software processes CT scans, generates contour data in DICOM RTSTRUCT format, and integrates with treatment planning systems to improve clinician workflow and efficiency in radiation therapy preparation.

HeartFlow Analysis is a software medical device that uses AI to analyze coronary CT angiography images. It provides detailed anatomical and physiological information about the coronary arteries, helping clinicians assess the risk and severity of coronary artery disease, aiding in treatment planning and diagnosis.

BriefCase by Aidoc Medical is an AI-powered software that analyzes head CT angiography images to detect suspected large and medium vessel occlusions. It assists trained medical specialists by providing notifications of suspected positive findings to help prioritize and triage cases for faster review. It operates alongside standard workflows without altering original medical images, helping clinicians identify urgent cases more quickly.

Genius AI Detection 2.0 is a software device that uses deep learning AI models to analyze digital breast tomosynthesis (DBT) images. It identifies and marks suspicious soft tissue densities and calcifications, providing confidence scores to aid radiologists during breast cancer screening. The AI improves detection specificity and reduces false positives, supporting clinicians in interpreting 3D mammography exams efficiently and accurately.

QIR Suite is a software tool designed to help medical professionals analyze cardiovascular magnetic resonance images. It uses standard and deep learning algorithms to automate measurements like heart chamber function and blood flow, aiding diagnosis and treatment planning for adult patients with heart conditions.

CogNet QmTRIAGE is an AI-powered software tool designed to analyze 2D digital mammograms to prioritize patients with suspicious breast findings. It flags exams suggestive of cancer to help mammography interpreting physicians prioritize their workflow, aiding early detection without replacing full diagnostic evaluation.

BriefCase is an artificial intelligence software that automatically analyzes CT chest with contrast scans to detect suspected cases of aortic dissection. It helps hospital networks and medical specialists by flagging possible cases to prioritize workflow and speed up patient triage. It provides notifications with preview images for informational use, aiding clinicians in prompt attention to urgent cases without replacing standard diagnostic procedures.