FDA 510(k)

開視

K 號：K172418 · 2018-09-21

決定日期2018-09-21

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

OpenSight is the device name listed in this FDA 510(k) record. The listed applicant is Novarad Corporation. It received FDA 510(k) clearance on 2018-09-21 under 510(k) number K172418. 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 OpenSight?

OpenSight is a medical device that received FDA 510(k) clearance on 2018-09-21. The listed applicant is Novarad Corporation. The 510(k) number is K172418.

When did OpenSight receive FDA 510(k) clearance?

OpenSight received FDA 510(k) clearance on 2018-09-21, under 510(k) number K172418.

Who is the listed applicant for OpenSight?

The FDA 510(k) record lists Novarad Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OpenSight?

The FDA product code for OpenSight is LLZ.

其他以 Novarad Corporation 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。

K220146VisAR K171754諾瓦PACS K160371諾瓦PACS

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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