GXR-ES/ECS 體檢X光系統，（型號GXR-ES系列，GXR-ECS系列）
K 號：K232178 · 2023-09-19
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器材摘要
常見問題
What is the GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)?
GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) is a medical device that received FDA 510(k) clearance on 2023-09-19. The listed applicant is DRGEM Corporation. The 510(k) number is K232178.
When did GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) receive FDA 510(k) clearance?
GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) received FDA 510(k) clearance on 2023-09-19, under 510(k) number K232178.
Who is the listed applicant for GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)?
The FDA 510(k) record lists DRGEM Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)?
The FDA product code for GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) is KPR.
相關臨床試驗
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其他以 DRGEM Corporation 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：KPR）
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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