ME-APDS™; MAGENTIQ-COLO™
K号: K223473 · 2023-07-25
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决定日期2023-07-25
产品代码QNP
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
ME-APDS™; MAGENTIQ-COLO™ is the device name listed in this FDA 510(k) record. The listed applicant is Magentiq Eye, Ltd.. It received FDA 510(k) clearance on 2023-07-25 under 510(k) number K223473. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ME-APDS™; MAGENTIQ-COLO™?
ME-APDS™; MAGENTIQ-COLO™ is a medical device that received FDA 510(k) clearance on 2023-07-25. The listed applicant is Magentiq Eye, Ltd.. The 510(k) number is K223473.
When did ME-APDS™; MAGENTIQ-COLO™ receive FDA 510(k) clearance?
ME-APDS™; MAGENTIQ-COLO™ received FDA 510(k) clearance on 2023-07-25, under 510(k) number K223473.
Who is the listed applicant for ME-APDS™; MAGENTIQ-COLO™?
The FDA 510(k) record lists Magentiq Eye, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ME-APDS™; MAGENTIQ-COLO™?
The FDA product code for ME-APDS™; MAGENTIQ-COLO™ is QNP.
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Magentiq Eye, Ltd.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。
相关器械（代码：QNP）
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。
K260133CADDIEOdin Medical LimitedK260567EW10-EC02 内窥镜支持程序Fujifilm CorporationK252853CAD - 下消化道（EC07-01）Xiamen Inno Medical Technology Co., Ltd.K261369GI Genius™ 模块 300 (GGM300-US)；ColonPRO™ US (CPRO403S-US)Cosmo Artificial Intelligence - Ai, Ltd.K260724MAGENTIQ-COLO (ME-APDS)Magentiq Eye, Ltd.K253664SKOUT 系统Iterative Health
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。
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