FLUOBEAM 800 system
Basic Information
- UDI-DI Code
- ++B475CSFB800NK
- Issuing Agency
- HIBCC
- Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Last Updated
- May 02, 2024
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.
Certificate Health
No certificates associated with this Basic UDI-DI.
Associated Devices
This Basic UDI-DI is associated with 6 devices.