FDA 510(k)

IntraMarX 3D 不透射线标记物

K号: K201106 · 2020-05-21

决定日期2020-05-21

产品代码FFX

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

IntraMarX 3D Radiopaque Marker is the device name listed in this FDA 510(k) record. The listed applicant is Anx Robotica Corp. It received FDA 510(k) clearance on 2020-05-21 under 510(k) number K201106. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IntraMarX 3D Radiopaque Marker?

IntraMarX 3D Radiopaque Marker is a medical device that received FDA 510(k) clearance on 2020-05-21. The listed applicant is Anx Robotica Corp. The 510(k) number is K201106.

When did IntraMarX 3D Radiopaque Marker receive FDA 510(k) clearance?

IntraMarX 3D Radiopaque Marker received FDA 510(k) clearance on 2020-05-21, under 510(k) number K201106.

Who is the listed applicant for IntraMarX 3D Radiopaque Marker?

The FDA 510(k) record lists Anx Robotica Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IntraMarX 3D Radiopaque Marker?

The FDA product code for IntraMarX 3D Radiopaque Marker is FFX.

列明Anx Robotica Corp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。

K241934NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)K230694NaviCam Xpress Stomach System, NaviCam Xpress System K221608NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether K203192NaviCam Xpress Stomach System K191087IntraMarX 不透射线标记物

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。