PEDRA-17F數位平面X光檢測器
K 號：K180989 · 2018-06-13
廣告
器材摘要
PEDRA-17F Digital Flat Panel X-ray Detector is the device name listed in this FDA 510(k) record. The listed applicant is Radisen, Inc.. It received FDA 510(k) clearance on 2018-06-13 under 510(k) number K180989. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the PEDRA-17F Digital Flat Panel X-ray Detector?
PEDRA-17F Digital Flat Panel X-ray Detector is a medical device that received FDA 510(k) clearance on 2018-06-13. The listed applicant is Radisen, Inc.. The 510(k) number is K180989.
When did PEDRA-17F Digital Flat Panel X-ray Detector receive FDA 510(k) clearance?
PEDRA-17F Digital Flat Panel X-ray Detector received FDA 510(k) clearance on 2018-06-13, under 510(k) number K180989.
Who is the listed applicant for PEDRA-17F Digital Flat Panel X-ray Detector?
The FDA 510(k) record lists Radisen, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PEDRA-17F Digital Flat Panel X-ray Detector?
The FDA product code for PEDRA-17F Digital Flat Panel X-ray Detector is MQB.
相關臨床試驗
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：MQB）
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。
K2538000909FCE，0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996通用1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530偵測器（Lux HD 2530）Iray Imaging Technology (Haining) LimitedK250211玉山X光平面面板檢測器Innocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.
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。
廣告