FDA Radiology AI Devices

Vent Creativity Knee v1.0 (Hermes) is a software tool that processes CT scan images of the knee to segment bones and generate surgical planning data. It uses AI models to accurately identify bone structures and landmarks, aiding clinicians in diagnosis and preoperative planning. The software also supports the creation of physical replicas based on imaging data, facilitating orthopedic applications.

The Starlight Imaging Catheter is a sterile, single-use catheter designed for imaging coronary arteries in patients undergoing transluminal interventional procedures. It uses near-infrared light and an internal rotating fiber optic core to capture detailed cross-sectional images inside vessels, helping clinicians assess vessel condition and guide interventions safely and effectively.

The EXPD 114 series are digital flat panel X-ray detectors designed to capture radiographic images electronically instead of traditional film. These devices convert incoming X-rays into visible light and then into digital signals for immediate viewing, storage, and analysis. The detectors are intended for general radiographic diagnosis and can replace traditional film or screen-based systems, assisting clinicians with quick and efficient patient imaging for a wide range of examinations in both adult and pediatric populations.

brAIn™ Shoulder Positioning is a cloud-based software tool that assists shoulder surgeons in planning total shoulder replacement surgeries. It automatically segments CT images of the shoulder using machine learning, allowing clinicians to visualize shoulder anatomy, position implants interactively in 3D, and receive detailed pre- and post-operative measurements and reports, facilitating more accurate and efficient surgical planning.

The EXPD-N series by DRTECH Corporation is a digital flat panel X-ray detector designed for use in digital radiography. It replaces traditional film or screen-based X-ray systems and aids clinicians by providing high-quality digital images for general diagnostic imaging of human anatomy in both adults and children. It supports improved imaging performance and faster image acquisition for better diagnosis.

The Broncho Videoscope System from Scivita Medical Technology Co. consists of single-use bronchoscopes and endoscopic image processors designed for endoscopic diagnosis and treatment within the respiratory system, including the trachea, bronchi, and lungs. This system provides real-time visualization on monitors, enabling clinicians to observe, diagnose, and treat respiratory conditions effectively in hospital settings.

PeekMed web is an AI-powered software system that helps healthcare professionals perform pre-operative planning for various surgical procedures using patients' imaging studies. It operates in 2D and 3D environments with support for musculoskeletal regions and incorporates automated AI models for bone segmentation and landmarking, improving efficiency and accuracy in surgical planning.

AVIEW is a software product that assists physicians by providing quantitative analysis of CT images for lung and cardiac evaluation. It offers segmentation of lung structures, characterization and measurement of lung nodules, calcium scoring of coronary arteries, and integrates computer-aided detection tools. It can be used both on-premises and in cloud environments, supporting remote access via mobile devices or browsers. This software enhances diagnostic accuracy and aids in patient management by automating complex image analysis tasks.

The Klarity SGRT System is a non-invasive, surface-guided radiation therapy device that uses 3D cameras and advanced software to continuously monitor patient positioning and breathing during radiotherapy. It helps clinicians accurately position patients and track respiratory motion to optimize treatment delivery and minimize radiation exposure to healthy tissues.

The Lux HD 35 Detector and Lux HD 43 Detector by iRay Imaging Technology are digital flat panel X-ray detectors designed to provide high-resolution digital radiographic imaging for adult and pediatric patients. These detectors replace traditional film/screen systems in general radiography and connect wirelessly or via wired interfaces to DR systems, aiding clinicians in capturing and processing X-ray images for diagnosis efficiently.