FDA Radiology AI Devices

qER-Quant is an AI-powered software that processes non-contrast head CT scans to automatically identify and quantify key brain structures such as intracranial hyperdensities, lateral ventricles, and midline shift. It helps clinicians by providing volumetric data and visual overlays to aid in diagnosis and monitoring brain conditions over time.

ClariCT.AI is an AI-powered software solution that enhances the quality of CT images by reducing noise, especially in low-dose scans. This helps radiologists get clearer images to improve diagnosis while potentially lowering patient radiation exposure. It is compatible with CT images from any manufacturer and integrates seamlessly with medical IT systems.

HALO is an AI-powered notification software that analyzes brain CT angiograms to detect signs of suspected intracranial Large Vessel Occlusion (LVO). It helps clinicians by promptly notifying appropriate medical specialists to facilitate quicker evaluation and treatment of stroke patients, improving emergency care and patient outcomes.

Precise Position is an AI-enabled accessory for Philips Incisive CT systems that assists technologists in accurately positioning patients before CT scans. It uses a ceiling-mounted camera to detect patient orientation, determine the scan range, and automatically center the patient's anatomy. This reduces positioning time and enhances accuracy for head, chest, abdomen, and pelvic CT imaging, ultimately improving imaging workflow and patient comfort.

CINA CHEST is an AI-powered software that analyzes chest and thoraco-abdominal CT angiography scans to detect signs of pulmonary embolism and aortic dissection. It helps radiologists prioritize cases by flagging suspected positive findings through notifications, thereby improving workflow efficiency and timely patient care. The tool works alongside standard image interpretation without altering original images and is not intended for diagnosis alone but as an aid for faster triage.

Preview Shoulder is a pre-operative planning software that helps orthopedic surgeons develop shoulder surgery plans by processing patient CT scans. The software reconstructs 3D models of the shoulder anatomy, allowing surgeons to digitally place implants and generate detailed surgical planning reports, thus aiding surgical preparation without providing diagnostic decisions.

Automatic Anatomy Recognition (AAR) is a software medical device that uses deep learning to automatically identify and contour anatomical structures from CT scans. It is designed to assist technicians and physicians in radiation therapy planning by providing precise contours of organs at risk in the head, neck, and chest areas. This helps improve the accuracy and efficiency of treatment planning for patients undergoing radiation therapy for cancers in these body regions.

AI Segmentation by Varian Medical Systems is a cloud-based AI software tool that segments patient anatomical structures from CT scans to assist radiation therapy treatment planning. It automatically delineates organs at risk in regions such as head and neck, thorax, pelvis, and abdomen, helping radiation therapy professionals by streamlining contouring tasks and integrating with treatment planning systems, though clinicians review and approve the results.

BriefCase for RibFx is an AI-powered software that assists medical specialists by analyzing chest CT scans to identify and flag cases with three or more acute rib fractures. It provides notifications and low-quality preview images on a desktop application, helping radiologists prioritize and review urgent cases sooner, thereby improving workflow efficiency and patient care.

DV.Target is a software product that uses machine learning algorithms to automatically delineate organs-at-risk on CT images. It supports radiation therapy planning by generating organ contours that clinicians can review and edit in a treatment planning system. The software operates on a server and integrates with clinical workflows through DICOM image routing.