PreXion3D 探索者 PRO
K 號：K221525 · 2022-07-22
廣告
器材摘要
PreXion3D Explorer PRO is the device name listed in this FDA 510(k) record. The listed applicant is Prexion Corporation. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K221525. 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 PreXion3D Explorer PRO?
PreXion3D Explorer PRO is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Prexion Corporation. The 510(k) number is K221525.
When did PreXion3D Explorer PRO receive FDA 510(k) clearance?
PreXion3D Explorer PRO received FDA 510(k) clearance on 2022-07-22, under 510(k) number K221525.
Who is the listed applicant for PreXion3D Explorer PRO?
The FDA 510(k) record lists Prexion Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PreXion3D Explorer PRO?
The FDA product code for PreXion3D Explorer PRO is OAS.
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。
其他以 Prexion 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：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。
K261748牙科圓錐束計算機斷層掃描儀（mDX-15P系列）Hefei Meyer Optoelectronic Technology, Inc.K250839牙科X光系統Changzhou Boen Zhongding Medical Technology Co., Ltd.K260662牙科圓锥束計算機斷層掃描系統Yofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093綠色X 12 VE (PHT-70CHS)；綠色X VE (PHT-70CHS)VATECH Co., Ltd.
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