AI-CVD
K号: K252029 · 2025-12-19
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器械摘要
AI-CVD is the device name listed in this FDA 510(k) record. The listed applicant is HeartLung Corporation. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K252029. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the AI-CVD?
AI-CVD is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is HeartLung Corporation. The 510(k) number is K252029.
When did AI-CVD receive FDA 510(k) clearance?
AI-CVD received FDA 510(k) clearance on 2025-12-19, under 510(k) number K252029.
Who is the listed applicant for AI-CVD?
The FDA 510(k) record lists HeartLung Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AI-CVD?
The FDA product code for AI-CVD is QIH.
列明HeartLung Corporation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。
相关器械（代码：QIH）
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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