FDA 510(k)

vascuCAP

K 號：K183012 · 2018-12-21

決定日期2018-12-21

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

vascuCAP is the device name listed in this FDA 510(k) record. The listed applicant is Elucid Bioimaging, Inc.. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K183012. 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 vascuCAP?

vascuCAP is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Elucid Bioimaging, Inc.. The 510(k) number is K183012.

When did vascuCAP receive FDA 510(k) clearance?

vascuCAP received FDA 510(k) clearance on 2018-12-21, under 510(k) number K183012.

Who is the listed applicant for vascuCAP?

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

What is the FDA product code for vascuCAP?

The FDA product code for vascuCAP is LLZ.

其他以 Elucid Bioimaging, Inc. 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。

K261855Elucid PlaqueIQ K241524Elucid PlaqueIQ K221463ElucidVivo A.3 K163071vascuCAP

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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