FDA 510(k)

CT肺通氣分析軟體（CT:V）

K 號：K232392 · 2023-11-16

決定日期2023-11-16

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

CT Lung Ventilation Analysis Software (CT:V) is the device name listed in this FDA 510(k) record. The listed applicant is 4Dmedical Limited. It received FDA 510(k) clearance on 2023-11-16 under 510(k) number K232392. 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 Lung Ventilation Analysis Software (CT:V)?

CT Lung Ventilation Analysis Software (CT:V) is a medical device that received FDA 510(k) clearance on 2023-11-16. The listed applicant is 4Dmedical Limited. The 510(k) number is K232392.

When did CT Lung Ventilation Analysis Software (CT:V) receive FDA 510(k) clearance?

CT Lung Ventilation Analysis Software (CT:V) received FDA 510(k) clearance on 2023-11-16, under 510(k) number K232392.

Who is the listed applicant for CT Lung Ventilation Analysis Software (CT:V)?

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 Lung Ventilation Analysis Software (CT:V)?

The FDA product code for CT Lung Ventilation Analysis Software (CT:V) is JAK.

其他以 4Dmedical Limited 為申請人之記錄

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K251484CT: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。)

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。

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官方來源

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