FDA 510(k)

EMMA 1.5T 魔力共振成像系統

K 號：K183621 · 2019-02-22

決定日期2019-02-22

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

EMMA 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 2019-02-22 under 510(k) number K183621. 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 EMMA 1.5T MRI System?

EMMA 1.5T MRI System is a medical device that received FDA 510(k) clearance on 2019-02-22. The listed applicant is Time Medical Limited. The 510(k) number is K183621.

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

EMMA 1.5T MRI System received FDA 510(k) clearance on 2019-02-22, under 510(k) number K183621.

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

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

其他以 Time Medical Limited 為申請人之記錄

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K222259NEONA 1.5T 魔力共振系統

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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