ArteraAI 乳腺
K号: K254115 · 2026-05-04
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器械摘要
ArteraAI Breast is the device name listed in this FDA 510(k) record. The listed applicant is Artera, Inc.. It received FDA 510(k) clearance on 2026-05-04 under 510(k) number K254115. The device is classified under product code SHW. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ArteraAI Breast?
ArteraAI Breast is a medical device that received FDA 510(k) clearance on 2026-05-04. The listed applicant is Artera, Inc.. The 510(k) number is K254115.
When did ArteraAI Breast receive FDA 510(k) clearance?
ArteraAI Breast received FDA 510(k) clearance on 2026-05-04, under 510(k) number K254115.
Who is the listed applicant for ArteraAI Breast?
The FDA 510(k) record lists Artera, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ArteraAI Breast?
The FDA product code for ArteraAI Breast is SHW.
相关临床试验
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。
相关器械（代码：SHW）
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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