FDA 510(k)

Discovery MR750 3.0T、Discovery MR450 1.5T、Discovery MR750w 3.0T、Optima MR450w 1.5T

K 號：K160618 · 2016-06-09

決定日期2016-06-09

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2016-06-09 under 510(k) number K160618. 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 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T?

Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T is a medical device that received FDA 510(k) clearance on 2016-06-09. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K160618.

When did Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T receive FDA 510(k) clearance?

Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T received FDA 510(k) clearance on 2016-06-09, under 510(k) number K160618.

Who is the listed applicant for Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T?

The FDA 510(k) record lists Ge Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T?

The FDA product code for Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T is LNH.

其他以 Ge Medical Systems, LLC 為申請人之記錄

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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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