FDA 510(k)

NEONA 1.5T 魔力共振系統

K 號：K222259 · 2023-02-21

決定日期2023-02-21

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

NEONA 1.5T MRI System is the device name listed in this FDA 510(k) record. The listed applicant is Time Medical Limited. It received FDA 510(k) clearance on 2023-02-21 under 510(k) number K222259. 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 NEONA 1.5T MRI System?

NEONA 1.5T MRI System is a medical device that received FDA 510(k) clearance on 2023-02-21. The listed applicant is Time Medical Limited. The 510(k) number is K222259.

When did NEONA 1.5T MRI System receive FDA 510(k) clearance?

NEONA 1.5T MRI System received FDA 510(k) clearance on 2023-02-21, under 510(k) number K222259.

Who is the listed applicant for NEONA 1.5T MRI System?

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

What is the FDA product code for NEONA 1.5T MRI System?

The FDA product code for NEONA 1.5T MRI System is LNH.

其他以 Time Medical Limited 為申請人之記錄

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。

K183621EMMA 1.5T 魔力共振成像系統

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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官方來源

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