FDA 510(k)

CT:VQ (注意：原文中未提供具体的医疗设备监管文本，因此无法进行翻译。请提供具体的文本内容以便进行翻译。)

K 號：K251484 · 2025-08-28

決定日期2025-08-28

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

CT:VQ is the device name listed in this FDA 510(k) record. The listed applicant is 4Dmedical Limited. It received FDA 510(k) clearance on 2025-08-28 under 510(k) number K251484. 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 CT:VQ?

CT:VQ is a medical device that received FDA 510(k) clearance on 2025-08-28. The listed applicant is 4Dmedical Limited. The 510(k) number is K251484.

When did CT:VQ receive FDA 510(k) clearance?

CT:VQ received FDA 510(k) clearance on 2025-08-28, under 510(k) number K251484.

Who is the listed applicant for CT:VQ?

The FDA 510(k) record lists 4Dmedical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT:VQ?

The FDA product code for CT:VQ is JAK.

其他以 4Dmedical Limited 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。

K232392CT肺通氣分析軟體（CT:V）

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

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。