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Fujifilm

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name
FUJIFILM FDA UDI
Generic Name
Endoscopic video image processing/light source system FDA UDI
Device Name
- 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. FDA UDI
Model / Reference
EP-8000 FDA UDI
Description
- 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. FDA UDI

Identifiers

Primary DI / UDI-DI
04547410513790 FDA UDI
510(k) Number
K243260 FDA UDI
FDA Product Code
FET FDA UDI
NTN FDA UDI
NWB FDA UDI
PEA FDA UDI
FDS FDA UDI
GMDN Term
Endoscopic video image processing/light source system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Hydrogen Peroxide FDA UDI

Category: Endoscopic video image processing/light source system

Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic video image processing/light source system.

Cleared under the same submission

K243260 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FUJIFILM Corporation

Sources (1)

  • FDA UDI fa54596a-b38f-4097-bca7-d5e3d9a23817 35 fields · synced Jun 8, 2026