Lung-CAD
K号: K230085 · 2023-10-03
广告
器械摘要
Lung-CAD is the device name listed in this FDA 510(k) record. The listed applicant is Imagen Technologies, Inc.. It received FDA 510(k) clearance on 2023-10-03 under 510(k) number K230085. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Lung-CAD?
Lung-CAD is a medical device that received FDA 510(k) clearance on 2023-10-03. The listed applicant is Imagen Technologies, Inc.. The 510(k) number is K230085.
When did Lung-CAD receive FDA 510(k) clearance?
Lung-CAD received FDA 510(k) clearance on 2023-10-03, under 510(k) number K230085.
Who is the listed applicant for Lung-CAD?
The FDA 510(k) record lists Imagen Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lung-CAD?
The FDA product code for Lung-CAD is MYN.
列明Imagen Technologies, Inc.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：MYN）
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。
广告