ECHELON 協奏曲 V10.0
K 號：K233687 · 2024-05-03
廣告
器材摘要
ECHELON Synergy V10.0 is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2024-05-03 under 510(k) number K233687. 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 ECHELON Synergy V10.0?
ECHELON Synergy V10.0 is a medical device that received FDA 510(k) clearance on 2024-05-03. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K233687.
When did ECHELON Synergy V10.0 receive FDA 510(k) clearance?
ECHELON Synergy V10.0 received FDA 510(k) clearance on 2024-05-03, under 510(k) number K233687.
Who is the listed applicant for ECHELON Synergy V10.0?
The FDA 510(k) record lists FUJIFILM Healthcare Americas Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ECHELON Synergy V10.0?
The FDA product code for ECHELON Synergy V10.0 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 FUJIFILM Healthcare Americas 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：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