PowerLook 梯度检测 V2 软件
K号: K182373 · 2018-12-06
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器械摘要
PowerLook Tomo Detection V2 Software is the device name listed in this FDA 510(k) record. The listed applicant is Icad, Inc.. It received FDA 510(k) clearance on 2018-12-06 under 510(k) number K182373. 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 PowerLook Tomo Detection V2 Software?
PowerLook Tomo Detection V2 Software is a medical device that received FDA 510(k) clearance on 2018-12-06. The listed applicant is Icad, Inc.. The 510(k) number is K182373.
When did PowerLook Tomo Detection V2 Software receive FDA 510(k) clearance?
PowerLook Tomo Detection V2 Software received FDA 510(k) clearance on 2018-12-06, under 510(k) number K182373.
Who is the listed applicant for PowerLook Tomo Detection V2 Software?
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 Tomo Detection V2 Software?
The FDA product code for PowerLook Tomo Detection V2 Software 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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