FDA 510(k)

Fluobeam LX

K-Number: K190891 · 2019-07-31

Decision Date2019-07-31

Product CodeQDG

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Fluobeam LX is the device name listed in this FDA 510(k) record. The listed applicant is Fluoptics. It received FDA 510(k) clearance on 2019-07-31 under 510(k) number K190891. 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?

Fluobeam LX is a medical device that received FDA 510(k) clearance on 2019-07-31. The listed applicant is Fluoptics. The 510(k) number is K190891.

When did Fluobeam LX receive FDA 510(k) clearance?

Fluobeam LX received FDA 510(k) clearance on 2019-07-31, under 510(k) number K190891.

Who is the listed applicant for Fluobeam LX?

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

What is the FDA product code for Fluobeam LX?

The FDA product code for Fluobeam LX 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)K230898FLUOBEAM® LX RedFluoptics Sas

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.