- Physicians Office Resource

CBL,PENTAX PROCESSOR TO PROVATION
N/A - 92199/35

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: 35.0 Feet

Length: 35.0 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: 04961333242566

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

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