Product Overview

N/A - 92092/12

Device Description

An electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Environmental Conditions

No Data Available

Device Sizes

  • Length: 10.0 Feet
    • Length: 10.0 Feet

    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: PEA

    Device Name: Endoscope, Accessories, Image Post-Processing For Color Enhancement

    Device Class: 2

    Physical State: The system consists of flexible and/or rigid scope(s), light source(s), video processor and display.

    Definition: Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.

    Submission Type ID: 1

    Review Panel: GU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Image enhancement using image post-processing algorithms of the received white light image with the goal of enhancing visualization of suspicious images seen on white light.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Limited to endoscopic systems for observation of the gastro-urological tract.

    Regulation Number: 876.1500

    Third Party Flag: N

    Medical Specialty: GU

    Device Identifiers

    Device Id: 04961333242306

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A

    Educational Resources