Camera Control Unit
1588 AIM - 1588010000
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
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OWN
Device Name: Confocal Optical Imaging
Device Class: 2
Physical State: Usually include optical fibers, light collection cameras and computer-based central processing unit
Definition: Collection of light signals for visualization of cellular microstructures.
Submission Type ID: 1
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Collects reflected and scattered light signals from the areas of interest for image reconstruction
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: soft tissue, blood vessel and other vessels in the body
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 07613327174328
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