# K190648: Pusen Eview Medical Video Endoscope Image Processor

- Pathway: 510(k) (Traditional)
- Applicant: Zhuhai Pusen Medical Technology Co., Ltd.
- Decided: Mar 29, 2019 after 16 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K944620 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131953: IMAGE1 Spies, KARL STORZ Endoscopy-America, Inc. (2013) Summary page 4.

## Most influential descendants
- K251734: ProVee Video Processing Unit (PV-003) (2025), 0 descendants of its own

## Indications for use
This equipment has been designed to be used to process signals from an endoscope and convert it to a signal that can be displayed on the monitor.

Source page: https://510kreport.com/device/K190648
Methodology: https://510kreport.com/methodology