FDA 510(k)

Visicoil MR 标记器（用户装载），Visicoil MR 标记器（预装载）

K号: K161724 · 2017-04-28

决定日期2017-04-28

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) is the device name listed in this FDA 510(k) record. The listed applicant is Radiomed Corporation. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K161724. 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 Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)?

Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Radiomed Corporation. The 510(k) number is K161724.

When did Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) receive FDA 510(k) clearance?

Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) received FDA 510(k) clearance on 2017-04-28, under 510(k) number K161724.

Who is the listed applicant for Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)?

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

What is the FDA product code for Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)?

The FDA product code for Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) is IYE.

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。

Visicoil MR 标记器（用户装载），Visicoil MR 标记器（预装载）

器械摘要

常见问题

相关临床试验

相关器械（代码：IYE）

官方来源