C4 标记物
K号: K192771 · 2020-10-21
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器械摘要
C4 Fiducial Marker is the device name listed in this FDA 510(k) record. The listed applicant is C4 Imaging, LLC. It received FDA 510(k) clearance on 2020-10-21 under 510(k) number K192771. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the C4 Fiducial Marker?
C4 Fiducial Marker is a medical device that received FDA 510(k) clearance on 2020-10-21. The listed applicant is C4 Imaging, LLC. The 510(k) number is K192771.
When did C4 Fiducial Marker receive FDA 510(k) clearance?
C4 Fiducial Marker received FDA 510(k) clearance on 2020-10-21, under 510(k) number K192771.
Who is the listed applicant for C4 Fiducial Marker?
The FDA 510(k) record lists C4 Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for C4 Fiducial Marker?
The FDA product code for C4 Fiducial Marker is NEU.
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。
列明C4 Imaging, LLC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：NEU）
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。
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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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