FDA Radiology AI Devices

The FUJIFILM Endoscope Model EB-710P is a flexible bronchoscope designed to observe, diagnose, and treat the trachea and bronchus. It works with the FUJIFILM Processor EP-8000, which provides illumination, processes visual signals from the endoscope, and enables image recording. This combination aids clinicians in examining airways more effectively under physician management.

Synapse 3D Base Tools (V7.0) is advanced medical imaging software from FUJIFILM designed to assist trained professionals in reading, interpreting, reporting, and planning treatment using images from various modalities such as CT, MRI, X-ray, ultrasound, and nuclear medicine. It provides powerful 3D viewing tools, image fusion, segmentation powered by deep learning, and supports multiple modalities and anatomical regions, which enhances diagnostic workflows and treatment planning for adult patients.

The FUJIFILM Processor EP-8000 and Endoscope Model EG-860R form a combined endoscopic video imaging system used in gastroenterology. The EP-8000 processor provides illumination with LED light sources and advanced image processing techniques to enhance visualization, while the EG-860R endoscope enables detailed examination and endoscopic treatment of the upper digestive tract. This system assists clinicians in diagnosing and treating conditions in the esophagus, stomach, and duodenum by delivering high-quality images and supporting multiple enhanced imaging modes.

The EW10-EC02 Endoscopy Support Program is an AI-driven software tool designed to support endoscopists by detecting colon polyps and adenomas in real time during standard colonoscopy exams. It processes real-time endoscopic video images from White Light Imaging and Linked Color Imaging to highlight potential lesions, helping clinicians improve diagnosis and patient outcomes without replacing clinical judgment.

Synapse 3D Base Tools v6.1 by Fujifilm is an advanced medical imaging software designed to assist trained medical professionals in viewing, analyzing, and interpreting medical images from a variety of modalities such as CT, MRI, PET, and ultrasound. It provides multi-planar reconstructions, 3D volume rendering, image fusion, segmentation using deep learning algorithms, and other sophisticated tools to support diagnosis and treatment planning, enhancing the workflow and accuracy for radiologists and clinicians.