麥克拉倫質子治療系統用X光成像系統
K 號：K181498 · 2018-12-10
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器材摘要
X-ray Imaging System for the McLaren Proton Treatment System is the device name listed in this FDA 510(k) record. The listed applicant is Ehmetdx, LLC. It received FDA 510(k) clearance on 2018-12-10 under 510(k) number K181498. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the X-ray Imaging System for the McLaren Proton Treatment System?
X-ray Imaging System for the McLaren Proton Treatment System is a medical device that received FDA 510(k) clearance on 2018-12-10. The listed applicant is Ehmetdx, LLC. The 510(k) number is K181498.
When did X-ray Imaging System for the McLaren Proton Treatment System receive FDA 510(k) clearance?
X-ray Imaging System for the McLaren Proton Treatment System received FDA 510(k) clearance on 2018-12-10, under 510(k) number K181498.
Who is the listed applicant for X-ray Imaging System for the McLaren Proton Treatment System?
The FDA 510(k) record lists Ehmetdx, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for X-ray Imaging System for the McLaren Proton Treatment System?
The FDA product code for X-ray Imaging System for the McLaren Proton Treatment System is LHN.
相關臨床試驗
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相關器械（代碼：LHN）
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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