PowerLook 密度评估 V4.0
K号: K211506 · 2021-07-12
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器械摘要
PowerLook Density Assessment V4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Icad, Inc.. It received FDA 510(k) clearance on 2021-07-12 under 510(k) number K211506. 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 PowerLook Density Assessment V4.0?
PowerLook Density Assessment V4.0 is a medical device that received FDA 510(k) clearance on 2021-07-12. The listed applicant is Icad, Inc.. The 510(k) number is K211506.
When did PowerLook Density Assessment V4.0 receive FDA 510(k) clearance?
PowerLook Density Assessment V4.0 received FDA 510(k) clearance on 2021-07-12, under 510(k) number K211506.
Who is the listed applicant for PowerLook Density Assessment V4.0?
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 PowerLook Density Assessment V4.0?
The FDA product code for PowerLook Density Assessment V4.0 is QIH.
相关临床试验
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列明Icad, 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：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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