開放大師，開放大師MSK
K 號：K212419 · 2022-02-04
廣告
器材摘要
Magnifico Open, Magnifico MSK is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K212419. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Magnifico Open, Magnifico MSK?
Magnifico Open, Magnifico MSK is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Esaote, S.p.A.. The 510(k) number is K212419.
When did Magnifico Open, Magnifico MSK receive FDA 510(k) clearance?
Magnifico Open, Magnifico MSK received FDA 510(k) clearance on 2022-02-04, under 510(k) number K212419.
Who is the listed applicant for Magnifico Open, Magnifico MSK?
FDA 510(k) 記錄將 Esaote, S.p.A. 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for Magnifico Open, Magnifico MSK?
The FDA product code for Magnifico Open, Magnifico MSK is LNH.
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 Esaote, S.p.A. 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：LNH）
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。
K261283APERTO Lucent MRI 系統Fujifilm CorporationK261758擁抱視覺新生兒MRI系統Aspect Imaging, Ltd.K260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd.K262622Swoop® 輕便式磁共振成像® 系統Hyperfine, Inc.K254250MagicScan-1.5，綠色MR寧靜1.5TXingaoyi Medical Equipment Co.,LtdK253808空氣偵探 DLGE Medical Systems
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