FDA 510(k)

Affirm 对比活检

K号: K202294 · 2020-10-05

决定日期2020-10-05

产品代码IZH

咨询委员会RA

决定实质等同

器械摘要

Affirm Contrast Biopsy is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2020-10-05 under 510(k) number K202294. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Affirm Contrast Biopsy?

Affirm Contrast Biopsy is a medical device that received FDA 510(k) clearance on 2020-10-05. The listed applicant is Hologic, Inc.. The 510(k) number is K202294.

When did Affirm Contrast Biopsy receive FDA 510(k) clearance?

Affirm Contrast Biopsy received FDA 510(k) clearance on 2020-10-05, under 510(k) number K202294.

Who is the listed applicant for Affirm Contrast Biopsy?

FDA 510(k)记录中列出了Hologic, 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 Affirm Contrast Biopsy?

The FDA product code for Affirm Contrast Biopsy is IZH.

列明Hologic, 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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