Pusen Eview Medical Video Endoscope Image Processor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K190648

by Zhuhai Pusen Medical Technology Co, Ltd

Identifiers

510(k) Number: K190648 FDA 510(k)
FDA Product Code: FET FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 876.1500 FDA 510(k)
Regulation Number: 876.1500 FDA 510(k)
Advisory Committee: Gastroenterology, Urology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Pusen Eview Medical Video Endoscope Image Processor is an endoscopic video imaging system/component designed for use in gastroenterology and urology procedures. It receives signals from a digital endoscope and displays clear HD images on a medical monitor, supporting detail enhancement for improved visualization during endoscopic examinations.

This device is intended for use in hospitals and qualified medical facilities. It is supplied as a reusable image processor and is regulated under FDA 510(k) clearance K190648 with product code FET and regulation number 876.1500. The device was determined to be substantially equivalent to a predicate device and received clearance on March 29, 2019.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Pusen Eview Medical Video Endoscope Image Processor (K190648) — FDA 510 ..., Pusen Eview Medical Video Endoscope Image Processor 510 (k) K190648 ..., Pusen PV220 | Medical Video Endoscope Image Processor

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K190648	Class II	Active

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Manufacturer

Manufacturer: Zhuhai Pusen Medical Technology Co, Ltd
FDA Applicant: Zhuhai Pusen Medical Technology Co., Ltd.

Sources (1)

FDA 510(k) K190648 24 fields · synced Sep 25, 2026