FDA 510(k)

神經節 PACS

K 號：K160108 · 2016-02-03

決定日期2016-02-03

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Synapse PACS 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 2016-02-03 under 510(k) number K160108. 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 PACS?

Synapse PACS is a medical device that received FDA 510(k) clearance on 2016-02-03. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K160108.

When did Synapse PACS receive FDA 510(k) clearance?

Synapse PACS received FDA 510(k) clearance on 2016-02-03, under 510(k) number K160108.

Who is the listed applicant for Synapse PACS?

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 PACS?

The FDA product code for Synapse PACS 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。

K261874Syneris PACS v.1.0.1.0Syneris K262442HipStudio分析Replasia BV K261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

官方來源

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