共聚焦微探头影像仪用成像探头审评要点浅析  

A Tentative Analysis of Technical Review for Imaging Probe Used by Fibered Confocal Microscopic Imaging System

作　　者：胡健 刘晓倩 蔡洋 HU Jian;LIU Xiao-qian;CAI Yang(Center for Medical Device Evaluation&Inspection of Hubei Medical Products Administration,Hubei Wuhan 430071)

机构地区：[1]湖北省药品监督管理局医疗器械审评检查中心,湖北武汉430071

出　　处：《中国医疗器械信息》2025年第1期20-22,83,共4页China Medical Device Information

摘　　要：成像探头是共聚焦微探头影像仪产品的关键组件,对最终的图像质量影响较大。此外,因为成像探头会进入人体腔道,直接接触人体组织,对人体具有一定的安全风险。但到目前为止,该产品尚无统一的标准或指导原则要求。文章从医疗器械技术审评角度,结合医疗器械注册申报资料要求以及其他现行法规和标准,浅析产品审评要点,以期对本类产品的注册申报及技术审评有所帮助。As the key component of the Fibered confocal microscopic imaging system,imaging probe has greatly effect on the quality of final image.Besides,the imaging probe may carries safety risks to human as it must enter the human body cavity and direct contact with tissue.So far,no unified standards or guidelines provided for this product.From the perspective of technical review of medical device and based on the requirements of medical device registration and related industry guidelines,the key review points been summary in the article in order to provide idea to the registration application and technical review of this kind of product in the future.

关 键 词：共聚焦微探头影像仪 成像探头 审评要点 

分 类 号：TH773[机械工程—仪器科学与技术]