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FDA 510(k)

MammoScreen® (5)

K号: K260714 · 2026-06-26

申请人Therapixel
决定日期2026-06-26
产品代码QDQ
咨询委员会RA
决定实质等同

器械摘要

MammoScreen® (5) is the device name listed in this FDA 510(k) record. The listed applicant is Therapixel. It received FDA 510(k) clearance on 2026-06-26 under 510(k) number K260714. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MammoScreen® (5)?

MammoScreen® (5) is a medical device that received FDA 510(k) clearance on 2026-06-26. The listed applicant is Therapixel. The 510(k) number is K260714.

When did MammoScreen® (5) receive FDA 510(k) clearance?

MammoScreen® (5) received FDA 510(k) clearance on 2026-06-26, under 510(k) number K260714.

Who is the listed applicant for MammoScreen® (5)?

The FDA 510(k) record lists Therapixel as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MammoScreen® (5)?

The FDA product code for MammoScreen® (5) is QDQ.

相关临床试验

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列明Therapixel为申报人的其他记录

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查看所有 7 个设备 →

相关器械(代码:QDQ)

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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