FDA 510(k)

FLUOBEAM LX 影像系統 (FBLX)；FLUOBEAM LM 影像系統 (FBLM)

K 號：K250455 · 2025-04-17

申請人Fluoptics Sas (A Getinge Group Company}

決定日期2025-04-17

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 Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) is the device name listed in this FDA 510(k) record. The listed applicant is Fluoptics Sas (A Getinge Group Company}. It received FDA 510(k) clearance on 2025-04-17 under 510(k) number K250455. 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 Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)?

FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) is a medical device that received FDA 510(k) clearance on 2025-04-17. The listed applicant is Fluoptics Sas (A Getinge Group Company}. The 510(k) number is K250455.

When did FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) receive FDA 510(k) clearance?

FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) received FDA 510(k) clearance on 2025-04-17, under 510(k) number K250455.

Who is the listed applicant for FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)?

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

What is the FDA product code for FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)?

The FDA product code for FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) is QDG.

其他以 Fluoptics Sas (A Getinge Group Company} 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。

K233564FLUOBEAM® LX 影像系統 (FB-LX)；FLUOBEAM® LX 紅外線影像系統 (FB-LXR)

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.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)K230898FLUOBEAM® LX 紅Fluoptics Sas K190891Fluobeam LXFluoptics

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。