FDA 510(k)

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

K号: K233564 · 2023-12-15

申请人Fluoptics Sas (A Getinge Group Company)

决定日期2023-12-15

产品代码QDG

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决定实质等同

器械摘要

FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) 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 2023-12-15 under 510(k) number K233564. 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 (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)?

FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Fluoptics Sas (A Getinge Group Company). The 510(k) number is K233564.

When did FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) receive FDA 510(k) clearance?

FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) received FDA 510(k) clearance on 2023-12-15, under 510(k) number K233564.

Who is the listed applicant for FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)?

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 (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)?

The FDA product code for FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) 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。

K250455FLUOBEAM LX 成像系统（FBLX）；FLUOBEAM LM 成像系统（FBLM）

官方来源

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