FDA 510(k)

3D超聲

K 號：K172513 · 2017-09-14

決定日期2017-09-14

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

3D Echo is the device name listed in this FDA 510(k) record. The listed applicant is Jointvue, LLC. It received FDA 510(k) clearance on 2017-09-14 under 510(k) number K172513. 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 3D Echo?

3D Echo is a medical device that received FDA 510(k) clearance on 2017-09-14. The listed applicant is Jointvue, LLC. The 510(k) number is K172513.

When did 3D Echo receive FDA 510(k) clearance?

3D Echo received FDA 510(k) clearance on 2017-09-14, under 510(k) number K172513.

Who is the listed applicant for 3D Echo?

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

What is the FDA product code for 3D Echo?

The FDA product code for 3D Echo is LLZ.

其他以 Jointvue, LLC 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。

K2116563D超聲v1.1 K173329jFit 外科計劃設備

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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