Akesis Galaxy RTx
K号: K200050 · 2020-02-04
广告
器械摘要
Akesis Galaxy RTx is the device name listed in this FDA 510(k) record. The listed applicant is Akesis, Inc.. It received FDA 510(k) clearance on 2020-02-04 under 510(k) number K200050. The device is classified under product code IWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Akesis Galaxy RTx?
Akesis Galaxy RTx is a medical device that received FDA 510(k) clearance on 2020-02-04. The listed applicant is Akesis, Inc.. The 510(k) number is K200050.
When did Akesis Galaxy RTx receive FDA 510(k) clearance?
Akesis Galaxy RTx received FDA 510(k) clearance on 2020-02-04, under 510(k) number K200050.
Who is the listed applicant for Akesis Galaxy RTx?
The FDA 510(k) record lists Akesis, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Akesis Galaxy RTx?
The FDA product code for Akesis Galaxy RTx is IWB.
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Akesis, 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。
相关器械（代码：IWB）
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。
K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon®); Leksell Gamma Knife® (Perfexion®)Elekta Solutions ABK232854Leksell GammaPlan (LGP)Elekta Solutions ABK222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (新型号变体)Elekta Solutions ABK203250TaiChiCOur United CorporationK203146Akesis Galaxy RTiAkesis, Inc.K190844Akesis GalaxyAkesis, Inc.
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