FDA Radiology AI Devices

The PRORAD X-Ray Flat Panel Detector with DROC is a digital radiography system designed to capture and display X-ray images of human anatomy. It is intended for general projection radiographic applications and helps clinicians by digitizing X-ray images for faster, more flexible image viewing and processing. The detector incorporates software that supports image workflow, viewing, measurement, and DICOM connectivity, streamlining radiographic exams and image management in clinical settings.

The IODR1717 / IODR1417 / IODR1417-GF detectors are digital flat panel X-ray detectors designed for high-quality digital radiography in general anatomical imaging for adults and children. They replace film-based systems and facilitate faster, streamlined digital radiography with wireless or wired connectivity, enhancing image acquisition and processing for clinicians.

Eclipse II with Smart Noise Cancellation is a software module integrated within the Carestream ImageView application that enhances digital radiography images by reducing noise using a Convolutional Neural Network. It supports various Carestream digital radiography detectors. This technology allows for up to 50% dose reduction in certain detector types without sacrificing image quality, helping clinicians obtain clearer x-ray images at lower radiation doses, thus improving patient safety and diagnostic confidence.

Intelligent NR is a software function integrated with Canon's CXDI Control Software that uses machine learning-based noise reduction to enhance the quality of digital X-ray images. It helps clinicians obtain clearer images from conventional radiographic exams, improving diagnostic confidence especially in trauma, intensive care, and pediatric settings.

Eclipse II with Smart Noise Cancellation is software that improves digital X-ray images by reducing noise using advanced AI technology. It enhances images acquired with digital radiography systems, helping radiologists see clearer images for better diagnosis of adult and pediatric patients, excluding mammography.