FDA 510(k)

MOBINEURO 阿莉塔手術中 MRI 系統

K 號：K223875 · 2023-03-20

申請人Sino Canada Health Engineering Research Institute (Hefei)

決定日期2023-03-20

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

MOBINEURO Alita Intraoperative MRI System is the device name listed in this FDA 510(k) record. The listed applicant is Sino Canada Health Engineering Research Institute (Hefei). It received FDA 510(k) clearance on 2023-03-20 under 510(k) number K223875. 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 MOBINEURO Alita Intraoperative MRI System?

MOBINEURO Alita Intraoperative MRI System is a medical device that received FDA 510(k) clearance on 2023-03-20. The listed applicant is Sino Canada Health Engineering Research Institute (Hefei). The 510(k) number is K223875.

When did MOBINEURO Alita Intraoperative MRI System receive FDA 510(k) clearance?

MOBINEURO Alita Intraoperative MRI System received FDA 510(k) clearance on 2023-03-20, under 510(k) number K223875.

Who is the listed applicant for MOBINEURO Alita Intraoperative MRI System?

The FDA 510(k) record lists Sino Canada Health Engineering Research Institute (Hefei) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOBINEURO Alita Intraoperative MRI System?

The FDA product code for MOBINEURO Alita Intraoperative MRI System is LNH.

相關器械（代碼：LNH）

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：LNH）

官方來源