FDA 510(k)

深度學習圖像重建

K 號：K230807 · 2023-04-20

決定日期2023-04-20

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

Deep Learning Image Reconstruction is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Japan Corporation. It received FDA 510(k) clearance on 2023-04-20 under 510(k) number K230807. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Deep Learning Image Reconstruction?

Deep Learning Image Reconstruction is a medical device that received FDA 510(k) clearance on 2023-04-20. The listed applicant is Ge Healthcare Japan Corporation. The 510(k) number is K230807.

When did Deep Learning Image Reconstruction receive FDA 510(k) clearance?

Deep Learning Image Reconstruction received FDA 510(k) clearance on 2023-04-20, under 510(k) number K230807.

Who is the listed applicant for Deep Learning Image Reconstruction?

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

What is the FDA product code for Deep Learning Image Reconstruction?

The FDA product code for Deep Learning Image Reconstruction is JAK.

其他以 Ge Healthcare Japan 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。

K253686真定義DL真實定義醫療設備規範文本注意事項： - 保留公司/產品名稱 - FDA（美國食品藥品管理局） - 510(k)（美國食品藥品管理局的510(k)許可程序） - PMA（美國食品藥品管理局的上市前批准） - NCT（臨床試驗登錄號） - PMID（PubMed標識符） - 標識符 - 網址規範政策：medical-regulatory-v1 請提供需要翻譯的文本，我將為您提供翻譯。K233698真實提升DL醫療設備規範文本：「本產品已通過FDA（美國食品藥品管理局）的510(k)認證，並符合PMA（上市前批准）標準。該產品參與的臨床試驗代號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。請參考以下識別碼和URL以獲取更多資訊：[識別碼] [URL]。」 Note: The placeholders [識別碼] and [URL] should be replaced with the actual identifiers and URLs.K220961深度學習圖像重建 K213938革命昇遠 K212067深度學習圖像重建 K203169革命昇遠

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相關器械（代碼：JAK）

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。

K261125BodyTom 64 (NL4100)；OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA 觀察階段 6.0Fujifilm Corporation K253836FCT iStream 階段 2Fujifilm Corporation K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company K253770卡迪克套件GE Medical Systems SCS K253560強化版PCCT邊界Ge Medical Systems, LLC

官方來源

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