Elekta Unity
K号: K223209 · 2023-02-23
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器械摘要
Elekta Unity is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Solutions AB. It received FDA 510(k) clearance on 2023-02-23 under 510(k) number K223209. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Elekta Unity?
Elekta Unity is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Elekta Solutions AB. The 510(k) number is K223209.
When did Elekta Unity receive FDA 510(k) clearance?
Elekta Unity received FDA 510(k) clearance on 2023-02-23, under 510(k) number K223209.
Who is the listed applicant for Elekta Unity?
FDA 510(k)记录中列出Elekta Solutions AB为申请人。这本身并不足以确定设备制造商。
What is the FDA product code for Elekta Unity?
The FDA product code for Elekta Unity is IYE.
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Elekta Solutions AB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。
K261932莱克塞尔® Vantage 立体定向系统K252002Monaco RTP系统（6.3）K252188EMLA (Elekta Evo)；EMLA (VersaHD)；EMLA (Elekta Harmony Pro)；EMLA (Elekta Infintiy)；EMLA (Elekta Harmony)；EMLA (Elekta Synergy)K251363ProKnow DSK250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon®); Leksell Gamma Knife® (Perfexion®)K232854Leksell GammaPlan (LGP)
相关器械（代码：IYE）
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。
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