FDA 510(k)

AutoContour Model RADAC V2

K号: K220598 · 2022-08-24

决定日期2022-08-24

产品代码QKB

咨询委员会RA

决定实质等同

器械摘要

AutoContour Model RADAC V2 is the device name listed in this FDA 510(k) record. The listed applicant is Radformation, Inc.. It received FDA 510(k) clearance on 2022-08-24 under 510(k) number K220598. 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 AutoContour Model RADAC V2?

AutoContour Model RADAC V2 is a medical device that received FDA 510(k) clearance on 2022-08-24. The listed applicant is Radformation, Inc.. The 510(k) number is K220598.

When did AutoContour Model RADAC V2 receive FDA 510(k) clearance?

AutoContour Model RADAC V2 received FDA 510(k) clearance on 2022-08-24, under 510(k) number K220598.

Who is the listed applicant for AutoContour Model RADAC V2?

FDA 510(k)记录中列出Radformation, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for AutoContour Model RADAC V2?

The FDA product code for AutoContour Model RADAC V2 is QKB.

列明Radformation, Inc.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。

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官方来源

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