FDA Radiology AI Devices

The EVIS EXERA III Bronchovideoscope series from Olympus Medical Systems Corp. includes several bronchoscopic models designed to provide high-quality endoscopic imaging within the airways and tracheobronchial tree. Integrated with Olympus video system centers, these bronchoscopes allow clinicians to perform diagnosis and endoscopic surgery with advanced imaging modes including Narrow Band Imaging (NBI), Red Dichromatic Imaging (RDI), Texture and Color Enhancement Imaging (TXI), and Blue Light Imaging - Multi-wavelength Active Light (BAI-MAC). The devices offer improved image quality, high resolution, and features such as pre-freeze and automatic brightness adjustment. They are compatible with EndoTherapy accessories for biopsy and treatment. These devices facilitate better visualization and maneuverability for clinicians during bronchoscopy procedures.

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.

The InsightersTM Single-use Bronchoscope System is a medical imaging device consisting of disposable flexible bronchoscopes and a compatible workstation display. It provides clear, real-time images for clinicians to observe, diagnose, and treat diseases affecting the trachea, bronchi, and lungs. The device enhances clinical workflow with its portability, image clarity, and single-use design to reduce risk of infection.

The LumiRex Bronchoscope is a single-use flexible endoscope designed to provide real-time video imaging of the airways and tracheobronchial tree. It aids clinicians during endoscopic procedures by allowing visualization through a thin tube equipped with a camera and light source. The device can operate in wired or wireless modes, enabling easier maneuverability, and is designed for use in hospitals.

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.

The Bronchoscope System by Shenzhen Sanping Image Technology Co. is a single-use flexible bronchoscope designed for use in hospital environments for adult patients. It works with an electronic endoscope imaging processor that captures images inside the airways and tracheobronchial tree using a CMOS image sensor and LED light source, then processes and displays these images on a monitor. This system helps clinicians perform endoscopic diagnosis and treatments safely and effectively with single-use, sterile instruments to reduce infection risks.

The MONARCH™ Platform is a robotic bronchoscopy system that provides physicians with precise, image-guided navigation and visualization of patient airways. It integrates electromagnetic tracking with real-time video from a flexible bronchoscope and can optionally update navigation using live imaging from Cone Beam CT scans. This aids clinicians in diagnosing and treating lung conditions with improved accuracy and control.