Fujifilm
The FUJIFILM Processor EP-8000 is an endoscopic video processor with an integrated light source. The FDA filing says it provides illumination, processes electronic signals from a video…
The FUJIFILM Processor EP-8000 is an endoscopic video processor with an integrated light source. The FDA filing says it provides illumination, processes electronic signals from a video endoscope and enables image recording.
The processor relays endoscope images to a video monitor and supplies air through the endoscope. It is described for endoscopic observation, diagnosis and treatment when used with compatible medical endoscopes, a monitor, a recorder and other peripherals.
Listed Item
– 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. – This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals. – It supplies air through the endoscope, for obtaining clear visualization and is used for endoscopic observation, diagnosis and treatment. – BLI (Blue Light Imaging), LCI (Linked Color Imaging), ACI (Amber-red Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examinations which can be used to supplement Fujifilm white light endoscopy. BLI, LCI, ACI and FICE are not intended to replace histopathological sampling as a means of diagnosis. – BLI, LCI, ACI and FICE are not intended for bronchoscopic examination.
Device Function and Details
The filing names BLI, LCI, ACI and FICE as adjunctive imaging tools for gastrointestinal examinations. It states these options supplement white-light imaging and are not intended to replace histopathological sampling for diagnosis.
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
| Shanghai Seegen Photoelectric Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Shenzhen Sophway Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Fujifilm Corporation, Japan |
|---|---|
| FDA product code | FET |
| Device type | Endoscopic Video Imaging System/Component, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K243260 |
| Record published | 2025-05-31 |
| Record revised | 2024-12-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Hydrogen Peroxide |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 85 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EP-8000 | In distribution | |
| BL-7000X | In distribution | |
| VS-1000 | In distribution | |
| VP-4440HD | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endocam | Richard Wolf Gmbh | 21 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Karl Storz GmbH & Co. KG | 20 |
| Gimmi | Gimmi Gmbh | 9 |
| Image 1 | Karl Storz GmbH & Co. KG | 8 |
| Exalt™ | Boston Scientific Corporation | 8 |
| Conmed | ConMed Corporation | 7 |
| Video Adapter | Olympus Medical Systems Corp. | 6 |
| EleVision™ | Schölly Fiberoptic GmbH | 6 |
| Evis Exera Colonovideoscope | Olympus Medical Systems Corp. | 5 |
| Water Resistant CAP | Olympus Medical Systems Corp. | 5 |
| CystoView™ | Verathon Medical (Canada) ULC | 5 |
| Riwo | Richard Wolf Gmbh | 5 |
Showing 12 of 105. All products under Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261880 | 2026-07-02 |
| K243260 | 2025-04-11 |
| K192286 | 2020-05-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.