FDA 510(k)

APERTO Lucent MRI 系統

K 號：K233629 · 2024-05-10

申請人FUJIFILM Healthcare Americas Corporation

決定日期2024-05-10

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

APERTO Lucent MRI System 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 2024-05-10 under 510(k) number K233629. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

什么是APERTO Lucent MRI系統？

APERTO Lucent MRI System is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K233629.

APERTO Lucent MRI系統是何時獲得FDA 510(k)許可的？

APERTO Lucent MRI System received FDA 510(k) clearance on 2024-05-10, under 510(k) number K233629.

誰是APERTO Lucent MRI系統的列名申請人？

The FDA 510(k) record lists FUJIFILM Healthcare Americas Corporation as the applicant. This does not by itself establish the device manufacturer.

FDA產品代碼是什麼？APERTO Lucent MRI系統的FDA產品代碼是什麼？

FDA產品代碼為APERTO Lucent MRI系統的是LNH。

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。

K261713Synapse PACS (7.6.0)K251204富士通 stiffening wire device (SW-2000)K243647Synapse PACS (7.5)K233321雙球囊內視鏡 EN-840T，超管 TS-1214C K233687ECHELON 協奏曲 V10.0 K233583FCT iSTREAM 開發階段 1

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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 Corporation K261758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.,Ltd K253808空氣偵探 DLGE Medical Systems

官方來源

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