体积样本成像仪
K号: K192939 · 2019-12-27
广告
器械摘要
Volumetric Specimen Imager is the device name listed in this FDA 510(k) record. The listed applicant is Clarix Imaging. It received FDA 510(k) clearance on 2019-12-27 under 510(k) number K192939. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Volumetric Specimen Imager?
Volumetric Specimen Imager is a medical device that received FDA 510(k) clearance on 2019-12-27. The listed applicant is Clarix Imaging. The 510(k) number is K192939.
When did Volumetric Specimen Imager receive FDA 510(k) clearance?
Volumetric Specimen Imager received FDA 510(k) clearance on 2019-12-27, under 510(k) number K192939.
Who is the listed applicant for Volumetric Specimen Imager?
The FDA 510(k) record lists Clarix Imaging as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Volumetric Specimen Imager?
The FDA product code for Volumetric Specimen Imager is MWP.
相关临床试验
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：MWP）
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。
K230136TrueView 200 Pro-US 样本射线摄影系统（TrueView 200 Pro-US）Compai Healthcare (Suzhou) Co.,LtdK230140TrueView Core 100Pro-US 核心标本射线摄影系统（TrueView Core 100Pro-US）Compai Healthcare (Suzhou) Co.,LtdK213691Solas ORCirdan Imaging, Ltd.K210955Kubtec Mozart Supra (XPERT 84) X射线系统Kub Technologies, Inc.K210956Kubtec Mozart (XPERT42)Kub Technologies, Inc.K210957Kubec Xpert 80 X射线系统Kub Technologies, Inc.
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