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FDA 510(k)

FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)

K-Number: K250455 · 2025-04-17

Decision Date2025-04-17
Product CodeQDG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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

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