FDA 510(k)

變更醫療健康 Stratus 匯影 PACS

K 號：K241981 · 2024-11-12

決定日期2024-11-12

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Change Healthcare Stratus Imaging PACS is the device name listed in this FDA 510(k) record. The listed applicant is Change Healthcare Canada Company. It received FDA 510(k) clearance on 2024-11-12 under 510(k) number K241981. 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 Change Healthcare Stratus Imaging PACS?

Change Healthcare Stratus Imaging PACS is a medical device that received FDA 510(k) clearance on 2024-11-12. The listed applicant is Change Healthcare Canada Company. The 510(k) number is K241981.

When did Change Healthcare Stratus Imaging PACS receive FDA 510(k) clearance?

Change Healthcare Stratus Imaging PACS received FDA 510(k) clearance on 2024-11-12, under 510(k) number K241981.

Who is the listed applicant for Change Healthcare Stratus Imaging PACS?

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

What is the FDA product code for Change Healthcare Stratus Imaging PACS?

The FDA product code for Change Healthcare Stratus Imaging PACS is LLZ.

其他以 Change Healthcare Canada Company 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。

K210719Change Healthcare 適用醫療設備規範文本 K181185變更醫療設備規範文本： Change Healthcare Enterprise Viewer

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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