FDA 510(k)

FLUOBEAM® LX 紅

K 號：K230898 · 2023-07-28

決定日期2023-07-28

產品代碼QDG

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

FLUOBEAM® LX Red is the device name listed in this FDA 510(k) record. The listed applicant is Fluoptics Sas. It received FDA 510(k) clearance on 2023-07-28 under 510(k) number K230898. The device is classified under product code QDG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FLUOBEAM® LX Red?

FLUOBEAM® LX Red is a medical device that received FDA 510(k) clearance on 2023-07-28. The listed applicant is Fluoptics Sas. The 510(k) number is K230898.

When did FLUOBEAM® LX Red receive FDA 510(k) clearance?

FLUOBEAM® LX Red received FDA 510(k) clearance on 2023-07-28, under 510(k) number K230898.

Who is the listed applicant for FLUOBEAM® LX Red?

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

What is the FDA product code for FLUOBEAM® LX Red?

The FDA product code for FLUOBEAM® LX Red is QDG.

相關器械（代碼：QDG）

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。

K253303樹突影像系統Dendrite Imaging, Inc.K250455FLUOBEAM LX 影像系統 (FBLX)；FLUOBEAM LM 影像系統 (FBLM)Fluoptics Sas (A Getinge Group Company}K233564FLUOBEAM® LX 影像系統 (FB-LX)；FLUOBEAM® LX 紅外線影像系統 (FB-LXR)Fluoptics Sas (A Getinge Group Company)K190891Fluobeam LXFluoptics

官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：QDG）

官方來源