FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)— 510(k) K233564

Name: FDA 510(k) clearance K233564
Creator: U.S. Food and Drug Administration
Published: 2023-12-15

Substantially Equivalent

Fluoptics Sas (A Getinge Group Company)

FDA 510(k) clearance K233564 for FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR), Substantially Equivalent on 2023-12-15. Applicant: Fluoptics Sas (A Getinge Group Company). Device class: 2.

Clearance details

Applicant: Fluoptics Sas (A Getinge Group Company)
Product code: Code QDG
Device class: Class 2
Regulation: 21 CFR 878.4550
Advisory panel: General, Plastic Surgery
Date received: 2023-11-06
Decision date: 2023-12-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Grenoble, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code QDG

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K253303 — Dendrite Imaging System2025-11-28
K250455 — FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)2025-04-17
K230898 — FLUOBEAM® LX Red2023-07-28
K190891 — Fluobeam LX2019-07-31
DEN170092 — Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System2018-11-02

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