FDA 510(k)

fiducial marker

K号: K211590 · 2021-06-10

决定日期2021-06-10

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

Fiducial Marker is the device name listed in this FDA 510(k) record. The listed applicant is Carbon Medical Technologies, Inc.. It received FDA 510(k) clearance on 2021-06-10 under 510(k) number K211590. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Fiducial Marker?

Fiducial Marker is a medical device that received FDA 510(k) clearance on 2021-06-10. The listed applicant is Carbon Medical Technologies, Inc.. The 510(k) number is K211590.

When did Fiducial Marker receive FDA 510(k) clearance?

Fiducial Marker received FDA 510(k) clearance on 2021-06-10, under 510(k) number K211590.

Who is the listed applicant for Fiducial Marker?

The FDA 510(k) record lists Carbon Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fiducial Marker?

The FDA product code for Fiducial Marker is IYE.

列明Carbon Medical Technologies, 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。

K253598InjecSURE 注射系统 K251748MammoSTAR活检位点标识器 K172227内窥镜注射针

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。