FDA 510(k)

I4（整合智能影像資訊學）系統

K 號：K160315 · 2016-02-19

申請人Philips Medical Systems Nederland B.V.

決定日期2016-02-19

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

I4 (Integrated Intelligent Imaging Informatics) system is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2016-02-19 under 510(k) number K160315. 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 I4 (Integrated Intelligent Imaging Informatics) system?

I4 (Integrated Intelligent Imaging Informatics) system is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K160315.

When did I4 (Integrated Intelligent Imaging Informatics) system receive FDA 510(k) clearance?

I4 (Integrated Intelligent Imaging Informatics) system received FDA 510(k) clearance on 2016-02-19, under 510(k) number K160315.

Who is the listed applicant for I4 (Integrated Intelligent Imaging Informatics) system?

FDA 510(k) 記錄將 Philips Medical Systems Nederland B.V. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for I4 (Integrated Intelligent Imaging Informatics) system?

The FDA product code for I4 (Integrated Intelligent Imaging Informatics) system is LLZ.

其他以 Philips Medical Systems Nederland B.V. 為申請人之記錄

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。

K254205Zenition 30 K262330dS乳頭 7ch 1.5TdS乳頭 7ch 3.0TdS乳頭 16ch 1.5TdS乳頭 16ch 3.0TdS乳頭線圈 7ch 1.5TdS Sentinelle乳頭 16ch 1.5TdS Sentinelle乳頭 16ch 3.0T K262294dS足踝16通道1.5T；dS足踝16通道3.0T；dS高解析手/腕16通道1.5T；dS高解析手/腕16CH 3.0T；dS小型 extremity 16通道1.5T；dS小型 extremity 16通道3.0T K260207多模態模擬工作空間（MM Sim）（v1.0.0）K253614EchoNavigator R5.0 K260169AV 心臟 CT

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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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