FDA 510(k)

FLUOBEAM LX 成像系统（FBLX）；FLUOBEAM LM 成像系统（FBLM）

K号: K250455 · 2025-04-17

申请人Fluoptics Sas (A Getinge Group Company}

决定日期2025-04-17

产品代码QDG

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Fluoptics Sas (A Getinge Group Company}为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K233564FLUOBEAM® LX 成像系统（FB-LX）；FLUOBEAM® LX 红成像系统（FB-LXR）

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。