FDA 510(k)

MOSAIQ® OIS（肿瘤学信息系统）

K号: K223229 · 2023-02-23

决定日期2023-02-23

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

MOSAIQ® OIS (Oncology Information 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 2023-02-23 under 510(k) number K223229. 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 MOSAIQ® OIS (Oncology Information System)?

MOSAIQ® OIS (Oncology Information System) 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 K223229.

When did MOSAIQ® OIS (Oncology Information System) receive FDA 510(k) clearance?

MOSAIQ® OIS (Oncology Information System) received FDA 510(k) clearance on 2023-02-23, under 510(k) number K223229.

Who is the listed applicant for MOSAIQ® OIS (Oncology Information 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 MOSAIQ® OIS (Oncology Information System)?

The FDA product code for MOSAIQ® OIS (Oncology Information System) is IYE.

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。