FDA 510(k)

FLUOBEAM® LX Red

K-Number: K230898 · 2023-07-28

Decision Date2023-07-28

Product CodeQDG

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: QDG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253303Dendrite Imaging SystemDendrite Imaging, Inc.K250455FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)Fluoptics Sas (A Getinge Group Company}K233564FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)Fluoptics Sas (A Getinge Group Company)K190891Fluobeam LXFluoptics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.