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FDA 510(k)

小型场发射器

K号: K220883 · 2022-12-15

决定日期2022-12-15
产品代码LHN
咨询委员会RA
决定实质等同

器械摘要

Small Field Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha. It received FDA 510(k) clearance on 2022-12-15 under 510(k) number K220883. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Small Field Applicator?

Small Field Applicator is a medical device that received FDA 510(k) clearance on 2022-12-15. The listed applicant is Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha. The 510(k) number is K220883.

When did Small Field Applicator receive FDA 510(k) clearance?

Small Field Applicator received FDA 510(k) clearance on 2022-12-15, under 510(k) number K220883.

Who is the listed applicant for Small Field Applicator?

The FDA 510(k) record lists Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Small Field Applicator?

The FDA product code for Small Field Applicator is LHN.

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Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha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:LHN)

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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