FDA 510(k)

Ziostation2

K 號：K200315 · 2020-05-05

決定日期2020-05-05

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Ziostation2 is the device name listed in this FDA 510(k) record. The listed applicant is Ziosoft, Inc.. It received FDA 510(k) clearance on 2020-05-05 under 510(k) number K200315. 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 Ziostation2?

Ziostation2 is a medical device that received FDA 510(k) clearance on 2020-05-05. The listed applicant is Ziosoft, Inc.. The 510(k) number is K200315.

When did Ziostation2 receive FDA 510(k) clearance?

Ziostation2 received FDA 510(k) clearance on 2020-05-05, under 510(k) number K200315.

Who is the listed applicant for Ziostation2?

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

What is the FDA product code for Ziostation2?

The FDA product code for Ziostation2 is LLZ.

其他以 Ziosoft, 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。

K181892Ziostation2

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。