iDMS 資料管理系統
K 號：K161144 · 2016-06-24
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器材摘要
iDMS Data Management System is the device name listed in this FDA 510(k) record. The listed applicant is Accuray Incorporated. It received FDA 510(k) clearance on 2016-06-24 under 510(k) number K161144. 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 iDMS Data Management System?
iDMS Data Management System is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is Accuray Incorporated. The 510(k) number is K161144.
When did iDMS Data Management System receive FDA 510(k) clearance?
iDMS Data Management System received FDA 510(k) clearance on 2016-06-24, under 510(k) number K161144.
Who is the listed applicant for iDMS Data Management System?
The FDA 510(k) record lists Accuray Incorporated as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iDMS Data Management System?
The FDA product code for iDMS Data Management System is IYE.
相關臨床試驗
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其他以 Accuray Incorporated 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。
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。
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。
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