FDA 510(k)

ClearCalc模型RADCA V2

K号: K220582 · 2022-08-22

决定日期2022-08-22

产品代码MUJ

咨询委员会RA

决定实质等同

器械摘要

ClearCalc Model RADCA 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 2022-08-22 under 510(k) number K220582. 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 ClearCalc Model RADCA V2?

ClearCalc Model RADCA V2 is a medical device that received FDA 510(k) clearance on 2022-08-22. The listed applicant is Radformation, Inc.. The 510(k) number is K220582.

When did ClearCalc Model RADCA V2 receive FDA 510(k) clearance?

ClearCalc Model RADCA V2 received FDA 510(k) clearance on 2022-08-22, under 510(k) number K220582.

Who is the listed applicant for ClearCalc Model RADCA 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 ClearCalc Model RADCA V2?

The FDA product code for ClearCalc Model RADCA V2 is MUJ.

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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