RTVue XR OCT Avanti 带AngioVue 软件
K号: K153080 · 2016-02-11
广告
决定日期2016-02-11
产品代码HLI
咨询委员会OP
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
RTVue XR OCT Avanti with AngioVue Software is the device name listed in this FDA 510(k) record. The listed applicant is Optovue, Inc.. It received FDA 510(k) clearance on 2016-02-11 under 510(k) number K153080. The device is classified under product code HLI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the RTVue XR OCT Avanti with AngioVue Software?
RTVue XR OCT Avanti with AngioVue Software is a medical device that received FDA 510(k) clearance on 2016-02-11. The listed applicant is Optovue, Inc.. The 510(k) number is K153080.
When did RTVue XR OCT Avanti with AngioVue Software receive FDA 510(k) clearance?
RTVue XR OCT Avanti with AngioVue Software received FDA 510(k) clearance on 2016-02-11, under 510(k) number K153080.
Who is the listed applicant for RTVue XR OCT Avanti with AngioVue Software?
The FDA 510(k) record lists Optovue, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RTVue XR OCT Avanti with AngioVue Software?
The FDA product code for RTVue XR OCT Avanti with AngioVue Software is HLI.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Optovue, Inc.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
广告