視覺雷達XR
K 號：K223133 · 2023-08-03
廣告
器材摘要
VisiRad XR is the device name listed in this FDA 510(k) record. The listed applicant is Imidex, Inc.. It received FDA 510(k) clearance on 2023-08-03 under 510(k) number K223133. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the VisiRad XR?
VisiRad XR is a medical device that received FDA 510(k) clearance on 2023-08-03. The listed applicant is Imidex, Inc.. The 510(k) number is K223133.
When did VisiRad XR receive FDA 510(k) clearance?
VisiRad XR received FDA 510(k) clearance on 2023-08-03, under 510(k) number K223133.
Who is the listed applicant for VisiRad XR?
The FDA 510(k) record lists Imidex, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VisiRad XR?
The FDA product code for VisiRad XR is MYN.
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：MYN）
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。
廣告