FDA 510(k)

動態視覺II圖像處理選項用於FDX控制台（DR-ID300CL的DR-ID600）

K 號：K163624 · 2017-06-30

決定日期2017-06-30

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-06-30 under 510(k) number K163624. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)?

Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) is a medical device that received FDA 510(k) clearance on 2017-06-30. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K163624.

When did Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) receive FDA 510(k) clearance?

Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) received FDA 510(k) clearance on 2017-06-30, under 510(k) number K163624.

Who is the listed applicant for Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)?

The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)?

The FDA product code for Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) is MQB.

其他以 Fujifilm Medical Systems U.S.A, Inc. 為申請人之記錄

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相關器械（代碼：MQB）

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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