点击进去后可以得到医疗器械更加详细的注册信息。一般的二类医疗器械都会有一个Summary可以点击,点击进去之后就会有可以洗在的一个网络文件,可以从中找到产品更加详细的注册信息和检测信息等。我们可以继续看一下右边的其他的数据库,从上往下依次为510K数据库(可以查询二类医疗器械);...
1、510K 510K认证适用于大部分II类医疗器械的产品上市。从审批通过的数据看，骨科、放射学、心血管、整...
To access this database, click this link:Redacted FOIA 510k Database. To limit your search to only 510k submissions that are available as a redacted full 510k, click on the box for “Redacted FOIA 510k.” If you want to learn more about how to make the most of this new resource, plea...
Premarket Approval(PMA)PMA提交是用来向FDA证明一个全新或者改动的设计的安全性和有效性，标准高于510k。...
510(k) Summary or 510(k) Statement 510K总结描述 - 相关信息链接:Device Advice "Content of a 510(k)" Section E 6 - 此部分是整个Submission report 最关键的一节, 包括提交者信息,产品信 息, 比对仪器信息,产品预期用途,等效比对,相关测试标准的描述; 本部分 ...
(AI) during the review of the 510k. In fact, during the RTA checklist review, FDA reviewers will often cite specific references to guidance documents if the company has not applied them. You will run across many “draft” guidance documents in the FDA database, some going as far back as...
要是按照 510K 方式的路径,还可以链接查询到相应 510 (k)的批准信息及相关资料,比如批准日期、510K summary(类似理解为批文)等。 需要注意的是,该数据库只包含已在美国上市的医疗器械,如果某个 OTC产品没有在该数据库中列出,很可能是该产品尚未在美国上市销售,不能因为没搜索到就判定其不存在或者不符合 OTC器械...
data transparency to promote further health equity in emerging technologies. The authors also note that in recent months, there have been additional AI/ML market approved devices added to the 510k database that have not been included in this evaluation. While this is a limitation, the authors ...
•510k文件所需要的信息是由质量体系中 的设计控制过程所产生的; • 实质等同SE对比在设计控制中已经完成确 认; 概述概述––质量体系法规质量体系法规21 CFR 820 21 CFR 820 OverviewOverview––QualityQualitySystem Regulation 21 CFR 820System Regulation 21 CFR 820 纠正预防措施 子部分J 纠正和预防措施 ...
Summary Background/objective When researchers or developers wish to apply their findings to clinical usages, it must be approved by public authorities such as the US Food and Drug Administration (FDA). In addition to the development records and risk control documents, all of the materials and ...