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510(k) Data Aggregation
K Number
K192704Device Name
Endofresh Digestive Endoscopy System
Manufacturer
Date Cleared
2020-09-02
(341 days)
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
HuiZhou Xzing Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
XZING-W200B Disposable GI Endoscope: The disposable GI endoscope (XZING-W200B) is designed to be used with XZING-S2 Camera System, monitor and other peripheral device for endoscopic observation, diagnosis and treatment of the adult upper gastrointestinal tract. It is a single use disposable device and cannot be reused.
XZING-C200B Disposable Colonoscope: The Disposable Colonoscope (XZING-C200B) is designed to be used with XZING-S2 Camera System, monitor and other peripheral device for electronic colonoscope observation, diagnosis and treatment of the adult lower digestive tract (including the anus, rectum, colon and ileocecal segment). It is a single use disposable device and cannot be reused.
XZING-S2 Camera System: The Camera System is designed to be used with the XZING endoscopes, monitor and other peripheral device for endoscopic observation, diagnosis and treatment.
Device Description
The proposed system, Endofresh Digestive Endoscopy System, includes a disposable GI endoscope, a disposable colonoscope and a camera system (refer to Table 1) They are used together with the monitor and other peripheral device for electronic endoscopic observation, diagnosis and treatment of adult upper gas trointestinal tract or adult lower digestive tract.
The disposable GI endoscope and disposable colonoscope are the hand-held, direct-viewing flexible endoscope used for endoscopy and endoscopic surgery within the upper and lower gastrointestinal tract. There are two LED lamps to provide illumination for endoscopic diagnosis, treatment and video observation. The disposable OI endoscope and disposable colonoscope are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.
The camera system is a video processing system which is designed to be used with the proposed endoscopes, monitor and other peripheral device. The camera system only has one imaging mode, white light imaging mode. Apat from the image processing functions, it also provides power supply for the endoscopes.
The display is not included in the Endofresh Digestive Endoscopy System. The display should have following color performance and color space to ensure the color performance of the whole system.
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