X-VIEW, 圖像
K 號：K151137 · 2016-06-07
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器材摘要
X-VIEW, IMAGEN is the device name listed in this FDA 510(k) record. The listed applicant is Edlen Imaging, LLC. It received FDA 510(k) clearance on 2016-06-07 under 510(k) number K151137. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the X-VIEW, IMAGEN?
X-VIEW, IMAGEN is a medical device that received FDA 510(k) clearance on 2016-06-07. The listed applicant is Edlen Imaging, LLC. The 510(k) number is K151137.
When did X-VIEW, IMAGEN receive FDA 510(k) clearance?
X-VIEW, IMAGEN received FDA 510(k) clearance on 2016-06-07, under 510(k) number K151137.
Who is the listed applicant for X-VIEW, IMAGEN?
The FDA 510(k) record lists Edlen Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for X-VIEW, IMAGEN?
The FDA product code for X-VIEW, IMAGEN is OAS.
相關臨床試驗
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相關器械（代碼：OAS）
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。
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官方來源
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