Aorta-CAD
K号: K213353 · 2022-09-20
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器械摘要
Aorta-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 2022-09-20 under 510(k) number K213353. 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 Aorta-CAD?
Aorta-CAD is a medical device that received FDA 510(k) clearance on 2022-09-20. The listed applicant is Imagen Technologies, Inc.. The 510(k) number is K213353.
When did Aorta-CAD receive FDA 510(k) clearance?
Aorta-CAD received FDA 510(k) clearance on 2022-09-20, under 510(k) number K213353.
Who is the listed applicant for Aorta-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 Aorta-CAD?
The FDA product code for Aorta-CAD is MYN.
相关临床试验
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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。
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