FDA 510(k)

iNtuition-結構心臟模組

K 號：K191585 · 2019-07-12

決定日期2019-07-12

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

iNtuition-Structural Heart Module is the device name listed in this FDA 510(k) record. The listed applicant is Terarecon,Inc.. It received FDA 510(k) clearance on 2019-07-12 under 510(k) number K191585. 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 iNtuition-Structural Heart Module?

iNtuition-Structural Heart Module is a medical device that received FDA 510(k) clearance on 2019-07-12. The listed applicant is Terarecon,Inc.. The 510(k) number is K191585.

When did iNtuition-Structural Heart Module receive FDA 510(k) clearance?

iNtuition-Structural Heart Module received FDA 510(k) clearance on 2019-07-12, under 510(k) number K191585.

Who is the listed applicant for iNtuition-Structural Heart Module?

The FDA 510(k) record lists Terarecon,Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iNtuition-Structural Heart Module?

The FDA product code for iNtuition-Structural Heart Module is LLZ.

其他以 Terarecon,Inc. 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。

K250288TeraRecon 心血管. 碳化. CT K243158TeraRecon 腹主动脉CT (1.1.0)K241312TeraRecon 心臟.心室.MR (1.0.0)K220349TeraRecon神經 K200750神經.艾爾演算法 K180916iNtuition-T1對照與T2/T2*對照

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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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