FDA 510(k)

IMRIS iMRI 3T V

K号: K212367 · 2021-08-23

决定日期2021-08-23

产品代码LNH

咨询委员会RA

决定实质等同

器械摘要

IMRIS iMRI 3T V is the device name listed in this FDA 510(k) record. The listed applicant is Deerfield Imaging, Inc.. It received FDA 510(k) clearance on 2021-08-23 under 510(k) number K212367. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IMRIS iMRI 3T V?

IMRIS iMRI 3T V is a medical device that received FDA 510(k) clearance on 2021-08-23. The listed applicant is Deerfield Imaging, Inc.. The 510(k) number is K212367.

When did IMRIS iMRI 3T V receive FDA 510(k) clearance?

IMRIS iMRI 3T V received FDA 510(k) clearance on 2021-08-23, under 510(k) number K212367.

Who is the listed applicant for IMRIS iMRI 3T V?

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

What is the FDA product code for IMRIS iMRI 3T V?

The FDA product code for IMRIS iMRI 3T V is LNH.

列明Deerfield Imaging, 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。

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