FDA 510(k)

Xmaru View V1 及 Xmaru PACS，醫學影像處理軟體

K 號：K160579 · 2016-04-08

決定日期2016-04-08

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Xmaru View V1 and Xmaru PACS, Medical Image Processing Software is the device name listed in this FDA 510(k) record. The listed applicant is Rayence Co., Ltd.. It received FDA 510(k) clearance on 2016-04-08 under 510(k) number K160579. 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 Xmaru View V1 and Xmaru PACS, Medical Image Processing Software?

Xmaru View V1 and Xmaru PACS, Medical Image Processing Software is a medical device that received FDA 510(k) clearance on 2016-04-08. The listed applicant is Rayence Co., Ltd.. The 510(k) number is K160579.

When did Xmaru View V1 and Xmaru PACS, Medical Image Processing Software receive FDA 510(k) clearance?

Xmaru View V1 and Xmaru PACS, Medical Image Processing Software received FDA 510(k) clearance on 2016-04-08, under 510(k) number K160579.

Who is the listed applicant for Xmaru View V1 and Xmaru PACS, Medical Image Processing Software?

FDA 510(k) 記錄將 Rayence Co., Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Xmaru View V1 and Xmaru PACS, Medical Image Processing Software?

The FDA product code for Xmaru View V1 and Xmaru PACS, Medical Image Processing Software is LLZ.

其他以 Rayence Co., Ltd. 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。

K2538000909FCE，0909FCE-HS K2438492430TCA 配合 Xmaru W K242394數位平面X光檢測器（1717WCE、1717WCE-HR、1717WCE-HS、1717WCE-GF）K2403710909FCC，0909FCC-HS K2314671417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF K220689Vatech 克里斯米爾

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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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