FDA 510(k)

維特瑞亞CT大腸分析

K 號：K160150 · 2016-03-16

決定日期2016-03-16

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Vitrea CT Colon Analysis is the device name listed in this FDA 510(k) record. The listed applicant is Vital Images, Inc.. It received FDA 510(k) clearance on 2016-03-16 under 510(k) number K160150. 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 Vitrea CT Colon Analysis?

Vitrea CT Colon Analysis is a medical device that received FDA 510(k) clearance on 2016-03-16. The listed applicant is Vital Images, Inc.. The 510(k) number is K160150.

When did Vitrea CT Colon Analysis receive FDA 510(k) clearance?

Vitrea CT Colon Analysis received FDA 510(k) clearance on 2016-03-16, under 510(k) number K160150.

Who is the listed applicant for Vitrea CT Colon Analysis?

The FDA 510(k) record lists Vital Images, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vitrea CT Colon Analysis?

The FDA product code for Vitrea CT Colon Analysis is LLZ.

其他以 Vital Images, 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。

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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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