FDA 510(k)

Viz CTP

K 號：K180161 · 2018-04-20

決定日期2018-04-20

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Viz CTP is the device name listed in this FDA 510(k) record. The listed applicant is Viz. Ai, Inc.. It received FDA 510(k) clearance on 2018-04-20 under 510(k) number K180161. 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 Viz CTP?

Viz CTP is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is Viz. Ai, Inc.. The 510(k) number is K180161.

When did Viz CTP receive FDA 510(k) clearance?

Viz CTP received FDA 510(k) clearance on 2018-04-20, under 510(k) number K180161.

Who is the listed applicant for Viz CTP?

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

What is the FDA product code for Viz CTP?

The FDA product code for Viz CTP is LLZ.

其他以 Viz. Ai, Inc. 為申請人之記錄

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K250354Viz Subdural+，Viz SUBDURAL PLUS K232363Viz HDS、Viz Volume Plus、Viz ICH+K223443Viz AAA K223042Viz LVO ContaCT K221100視覺 RV/LV K220439Viz SDH

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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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