ProFound AI 软件 V3.0
K号: K203822 · 2021-03-12
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器械摘要
ProFound AI Software V3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Icad, Inc.. It received FDA 510(k) clearance on 2021-03-12 under 510(k) number K203822. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ProFound AI Software V3.0?
ProFound AI Software V3.0 is a medical device that received FDA 510(k) clearance on 2021-03-12. The listed applicant is Icad, Inc.. The 510(k) number is K203822.
When did ProFound AI Software V3.0 receive FDA 510(k) clearance?
ProFound AI Software V3.0 received FDA 510(k) clearance on 2021-03-12, under 510(k) number K203822.
Who is the listed applicant for ProFound AI Software V3.0?
The FDA 510(k) record lists Icad, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ProFound AI Software V3.0?
The FDA product code for ProFound AI Software V3.0 is QDQ.
相关临床试验
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列明Icad, Inc.为申报人的其他记录
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相关器械（代码：QDQ）
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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