FDA 510(k)

IMRIS iMRI 3T V

K 號：K212367 · 2021-08-23

決定日期2021-08-23

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Deerfield Imaging, Inc. 為申請人之記錄

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K240157InVision™ 1.5 外科手术室

相關器械（代碼：LNH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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