FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000
FUJIFILM CorporationThe 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.
Intended Use
Endoscope Model EB-710P is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus under physician management. Processor EP-8000 provides illumination, processes electronic signals from a video endoscope, and enables image recording used for endoscopic observation, diagnosis and treatment.
Technology
The EB-710P is a flexible bronchoscope composed of an insertion portion with glass fiber bundles, CMOS image sensor and channels, a control portion for angulation and rotation, and a connector portion for video processor connection. The EP-8000 is a video processor with an integrated light source using four LED lamps (violet, blue, green, amber) to illuminate body cavities and process signals from the endoscope to display and record images.
Performance
The EP-8000 was tested for electrical safety and software validation according to relevant standards. Bench testing demonstrated substantial equivalence to predicate devices in white light imaging mode performance including color reproduction, geometric distortion, resolution, depth of field, SNR, image uniformity, and field of view. Risk analysis confirmed no new safety or effectiveness issues with added features such as tablet operation.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/27/2024
5 months - 2
FDA Approval
6/13/2025
Other devices from FUJIFILM Corporation
- Synapse 3D Base Tools (V7.0)2025 • 510K
- SCENARIA View Phase 5.02025 • 510K
- FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R2025 • 510K
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