FDA 510(k)

Monaco Rtp系统

K号: K202789 · 2021-02-23

决定日期2021-02-23

产品代码MUJ

咨询委员会RA

决定实质等同

器械摘要

Monaco Rtp System 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 2021-02-23 under 510(k) number K202789. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Monaco Rtp System?

Monaco Rtp System is a medical device that received FDA 510(k) clearance on 2021-02-23. The listed applicant is Elekta Solutions AB. The 510(k) number is K202789.

When did Monaco Rtp System receive FDA 510(k) clearance?

Monaco Rtp System received FDA 510(k) clearance on 2021-02-23, under 510(k) number K202789.

Who is the listed applicant for Monaco Rtp System?

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 Monaco Rtp System?

The FDA product code for Monaco Rtp System is MUJ.

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 DS K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon®); Leksell Gamma Knife® (Perfexion®)K232854Leksell GammaPlan (LGP)

查看所有 15 个设备 →

官方来源

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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。