Eu Mdr Eu Md Class 2a On The Market

VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES

FLUOBEAM 800 including FLUOSOFT 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. FLUOBEAM 800 including FLUOSOFT is indicated to facilitate the visualization of parathyroid glands by auto-fluorescence (natural fluorescence without ICG injection) during thyroid and parathyroid surgeries.

Devices (same UDI-DI)
6
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
+B475CSFB800PCA/CL0
Basic UDI-DI Code
++B475CSFB800NK
Reference
CS_FB800_PC_A
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market

Additional Description

Complementary solution without suitcase

Medical Purpose

FLUOBEAM 800 including FLUOSOFT 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. FLUOBEAM 800 including FLUOSOFT is indicated to facilitate the visualization of parathyroid glands by auto-fluorescence (natural fluorescence without ICG injection) during thyroid and parathyroid surgeries.

CND Nomenclature Codes

Code Description
Z119080 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES

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