FDA 510(k)

Affirm 俯卧活检系统

K号: K153486 · 2016-04-01

决定日期2016-04-01

产品代码IZH

咨询委员会RA

决定实质等同

器械摘要

Affirm Prone Biopsy System is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2016-04-01 under 510(k) number K153486. 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 Prone Biopsy System?

Affirm Prone Biopsy System is a medical device that received FDA 510(k) clearance on 2016-04-01. The listed applicant is Hologic, Inc.. The 510(k) number is K153486.

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

Affirm Prone Biopsy System received FDA 510(k) clearance on 2016-04-01, under 510(k) number K153486.

Who is the listed applicant for Affirm Prone Biopsy System?

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 Prone Biopsy System?

The FDA product code for Affirm Prone Biopsy System 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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