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FDA 510(k)

AI-Rad Companion器官实时放疗

K号: K252548 · 2026-04-10

决定日期2026-04-10
产品代码QKB
咨询委员会RA
决定实质等同

器械摘要

AI-Rad Companion Organs RT is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K252548. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AI-Rad Companion Organs RT?

AI-Rad Companion Organs RT is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Siemens Healthcare GmbH. The 510(k) number is K252548.

When did AI-Rad Companion Organs RT receive FDA 510(k) clearance?

AI-Rad Companion Organs RT received FDA 510(k) clearance on 2026-04-10, under 510(k) number K252548.

Who is the listed applicant for AI-Rad Companion Organs RT?

The FDA 510(k) record lists Siemens Healthcare GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AI-Rad Companion Organs RT?

The FDA product code for AI-Rad Companion Organs RT is QKB.

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列明Siemens Healthcare GmbH为申报人的其他记录

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相关器械(代码:QKB)

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

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