MammoScreen® (3)
K号: K240301 · 2024-08-01
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器械摘要
MammoScreen® (3) is the device name listed in this FDA 510(k) record. The listed applicant is Therapixel. It received FDA 510(k) clearance on 2024-08-01 under 510(k) number K240301. 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® (3)?
MammoScreen® (3) is a medical device that received FDA 510(k) clearance on 2024-08-01. The listed applicant is Therapixel. The 510(k) number is K240301.
When did MammoScreen® (3) receive FDA 510(k) clearance?
MammoScreen® (3) received FDA 510(k) clearance on 2024-08-01, under 510(k) number K240301.
Who is the listed applicant for MammoScreen® (3)?
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® (3)?
The FDA product code for MammoScreen® (3) 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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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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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