Endoscopic image processing software - NMPA Registration 粤械注准20242210939
Access comprehensive regulatory information for Endoscopic image processing software in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20242210939 and owned by Sonoscape MEDICAL Corp.. The device was approved on July 15, 2024.
This page provides complete registration details including registrant information, province location (Guangdong), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
This product is suitable for receiving, displaying, processing and storing images of the upper gastrointestinal tract, and assisting in the identification and endoscopic operation of the digestive tract during the electronic endoscopy of the upper gastrointestinal tract (esophagus, stomach, duodenum). This product is used to assist in the identification of parts of the normal upper gastrointestinal tract, and does not have the function of lesion identification and automatic diagnosis.
本产品适用于对上消化道影像的接收、显示、处理与存储，在上消化道（食管、胃、十二指肠）电子内窥镜检查过程中辅助消化道部位识别及内镜操作。本产品用于正常上消化道的部位辅助识别，不具有病变识别及自动诊断功能。
The product is installed and delivered through a USB installation disk, and the release version number is V1.0. The functional module includes the upper gastrointestinal tract image display module, the upper gastrointestinal tract part recognition module, the time-consuming and recording module, and the system management module.
产品通过USB安装盘安装交付，发布版本号为V1.0。功能模块包括上消化道影像显示模块、上消化道部位识别模块、耗时和记录模块、系统管理模块。