FDA 510(k)

PACS核心/ENCORE

K 號：K161518 · 2016-08-17

申請人Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.

決定日期2016-08-17

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

PACS CORE/ENCORE is the device name listed in this FDA 510(k) record. The listed applicant is Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. It received FDA 510(k) clearance on 2016-08-17 under 510(k) number K161518. 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 PACS CORE/ENCORE?

PACS CORE/ENCORE is a medical device that received FDA 510(k) clearance on 2016-08-17. The listed applicant is Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. The 510(k) number is K161518.

When did PACS CORE/ENCORE receive FDA 510(k) clearance?

PACS CORE/ENCORE received FDA 510(k) clearance on 2016-08-17, under 510(k) number K161518.

Who is the listed applicant for PACS CORE/ENCORE?

The FDA 510(k) record lists Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PACS CORE/ENCORE?

The FDA product code for PACS CORE/ENCORE is LLZ.

其他以 Compania Mexicana DE Radiologia Cgr, S.A. DE C.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。

K193637MRH ALFA 放射學系統，MRH II 放射學系統，MRH IIE 放射學系統 K182134ARiX RAD射線學系統

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

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