FLUOBEAM LX system

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref CS_FBLX_PC_A510(k) K190891

Identity

Primary DI / UDI-DI: +B475CSFBLXPCA/CL0 EUDAMED
Basic UDI-DI: ++B475CSFBLXY2 EUDAMED
EMDN Code: Z119080 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED

Device Class: Class IIa EUDAMED
Medical Purpose: FLUOBEAM LX including FLUOSOFT LX is indicated to facilitate the visualization of parathyroid glands by auto-fluorescence (natural fluorescence without ICG injection) during thyroid and parathyroid surgeries. FLUOBEAM LX including FLUOSOFT LX is indicated to visualize on a screen the flow, the distribution and/ or the accumulation of Indocyanine green (ICG) before, during and after surgery for the indications such as: • visualization of blood flow, • visualization of lymph flow, • visualization and identification of bile ducts during hepatobiliary surgery, • visualization and detection of primary liver tumors and/or hepatic metastases. EUDAMED

Sterile

EUDAMED

FLUOBEAM LX system by Fluoptics Sas — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K190891	Class IIa	Active
EUDAMED	European Union	CE/MDR	++B475CSFBLXY2	Class IIa	Active

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