FDA 510(k)

ThinkQA 注意：此文本為翻譯版本，以下為翻譯內容： ThinkQA 注意事項：此文本為翻譯版本，以下為翻譯內容： ThinkQA

K 號：K180106 · 2018-03-13

決定日期2018-03-13

產品代碼IYE

諮詢委員會RA

決定相當於

器材摘要

ThinkQA is the device name listed in this FDA 510(k) record. The listed applicant is Dosisoft. It received FDA 510(k) clearance on 2018-03-13 under 510(k) number K180106. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ThinkQA?

ThinkQA is a medical device that received FDA 510(k) clearance on 2018-03-13. The listed applicant is Dosisoft. The 510(k) number is K180106.

When did ThinkQA receive FDA 510(k) clearance?

ThinkQA received FDA 510(k) clearance on 2018-03-13, under 510(k) number K180106.

Who is the listed applicant for ThinkQA?

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

What is the FDA product code for ThinkQA?

The FDA product code for ThinkQA is IYE.

其他以 Dosisoft 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。

K191944MU2net K182966地球癌劑量計

相關器械（代碼：IYE）

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。

K261865AerFrame™ 對齊雷射箱 (LBV2)Stabilix, LLC K261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA 放射治療資訊系統 (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos 放射治療系統 (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SA K253004LUNA 3DLap GmbH Laser Applikationen

官方來源

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