FDA 510(k)

MammoSightAI

K号: K252954 · 2026-05-04

决定日期2026-05-04

产品代码QFM

咨询委员会RA

决定实质等同

器械摘要

MammoSightAI is the device name listed in this FDA 510(k) record. The listed applicant is Neurocareai, Inc. (Dba Savelife.Ai). It received FDA 510(k) clearance on 2026-05-04 under 510(k) number K252954. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MammoSightAI?

MammoSightAI is a medical device that received FDA 510(k) clearance on 2026-05-04. The listed applicant is Neurocareai, Inc. (Dba Savelife.Ai). The 510(k) number is K252954.

When did MammoSightAI receive FDA 510(k) clearance?

MammoSightAI received FDA 510(k) clearance on 2026-05-04, under 510(k) number K252954.

Who is the listed applicant for MammoSightAI?

FDA 510(k)记录将Neurocareai，Inc.（商业名称Savelife.Ai）列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for MammoSightAI?

The FDA product code for MammoSightAI is QFM.

列明Neurocareai, Inc. (Dba Savelife.Ai)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。

K260936RadioViewAI 请注意，由于“RadioViewAI”是一个设备名称，通常情况下，设备名称不需要翻译，除非它包含有特定文化或语言含义的词汇。因此，在此情况下，我保留了原始名称“RadioViewAI”不变。如果需要将整个句子或描述翻译成中文，请提供完整的句子或描述。K253751CXRDetectAI

官方来源

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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。