FDA 510(k)

合併PACS

K 號：K192455 · 2019-10-17

決定日期2019-10-17

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Merge PACS is the device name listed in this FDA 510(k) record. The listed applicant is Merge Healthcare Incorporated. It received FDA 510(k) clearance on 2019-10-17 under 510(k) number K192455. 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 Merge PACS?

Merge PACS is a medical device that received FDA 510(k) clearance on 2019-10-17. The listed applicant is Merge Healthcare Incorporated. The 510(k) number is K192455.

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

Merge PACS received FDA 510(k) clearance on 2019-10-17, under 510(k) number K192455.

Who is the listed applicant for Merge PACS?

The FDA 510(k) record lists Merge Healthcare Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Merge PACS?

The FDA product code for Merge PACS is LLZ.

其他以 Merge Healthcare Incorporated 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。

K250301合併通用視覺器（MUV）K233326合併Hemo，型號RCSV2 K203104IBM iConnect Access K192276合併心臟設備醫療設備規範文本合併心臟設備 FDA（美國食品藥品管理局） 510(k)（美國食品藥品管理局的510(k)認證程序） PMA（美國食品藥品管理局的上市前批准） NCT（臨床試驗登錄號） PMID（PubMed標識符）識別碼網址政策：醫療規範-v1 K182290IBM iConnect Access K173475合併PACS

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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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