FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R
Fujifilm CorporationThe 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.
Intended Use
The EP-8000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording. The EG-860R is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Technology
The EP-8000 processor employs fiber bundles to transmit light from four LED lamps to illuminate the body cavity, processes electronic signals transmitted from the video endoscope, and relays images to a video monitor with enhanced imaging options including Blue Light Imaging (BLI), Linked Color Imaging (LCI), Amber-red Color Imaging (ACI), and Flexible spectral Imaging Color Enhancement (FICE). The EG-860R endoscope has a flexible bending portion, CMOS image sensor, glass fiber bundles for light transmission, and channels for instruments and air/water supply allowing visualization and treatment during endoscopy.
Performance
The performance of the EP-8000 processor imaging modes and the EG-860R endoscope were evaluated against engineering requirements including color reproduction, image resolution, geometric distortion, depth of field, signal to noise ratio, dynamic range, illumination uniformity, and functional parameters related to bending and suction. Testing demonstrated substantial equivalence to predicate devices with no new issues of safety or effectiveness raised.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/15/2024
5 months - 2
FDA Approval
4/11/2025
Other devices from Fujifilm Corporation
- FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-80002025 • 510K
- Synapse 3D Base Tools (V7.0)2025 • 510K
- SCENARIA View Phase 5.02025 • 510K
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