FDA Radiology AI Devices

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.

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 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.

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 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.

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.

Radlink GPS Pro Imaging is an advanced image processing software that assists orthopedic surgeons in hip procedures by measuring the acetabulum’s position relative to bone structures seen in radiological images. The software overlays digital annotations on images and offers measurement tools to help surgeons plan and execute hip, knee, and trauma component positioning more precisely, improving procedural accuracy and outcomes.

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.

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.

QP-Prostate® CAD is an artificial intelligence-based software that helps doctors detect and identify suspicious lesions in the prostate gland using bi-parametric prostate MRI. It highlights areas of concern on the images to assist physicians during their interpretation but should be used alongside other clinical information. It seamlessly integrates with existing DICOM imaging systems and PACS, improving the diagnostic workflow for prostate cancer detection.