FDA 510(k)

Synapse 3D灌流分析

K 號：K162287 · 2017-04-06

決定日期2017-04-06

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Synapse 3D Perfusion Analysis 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 2017-04-06 under 510(k) number K162287. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Synapse 3D Perfusion Analysis?

Synapse 3D Perfusion Analysis is a medical device that received FDA 510(k) clearance on 2017-04-06. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K162287.

When did Synapse 3D Perfusion Analysis receive FDA 510(k) clearance?

Synapse 3D Perfusion Analysis received FDA 510(k) clearance on 2017-04-06, under 510(k) number K162287.

Who is the listed applicant for Synapse 3D Perfusion Analysis?

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 Synapse 3D Perfusion Analysis?

The FDA product code for Synapse 3D Perfusion Analysis is LLZ.

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：LLZ）

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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