Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K233564 · 2023-12-15

Decision Date2023-12-15
Product CodeQDG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Fluoptics Sas (A Getinge Group Company) as applicant

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.

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.

Official Source

View on FDA Database →

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