mauna kea

mauna kea

Cellvizio® Endomicroscopy in the GI tract Mauna Kea Technologies

2d ago
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Description

Intended use The Cellvizio® 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that is intended to allow imaging of the internal microstructure of tissues in anatomical tracts, i.e., gastrointestinal or respiratory, accessed by an endoscope or endoscopic accessories. The Cellvizio System is a regulated Medical Device, CE marked (Class IIa - NB : LNE/GMED) and FDA cleared. Disclaimer: Please note that the interpretation criteria are suggested descriptive features and do note represent definitive features and do not represent definitive diagnostic landmarks and are a result of input from trained and well qualified personnel. The page title used are for convinience and not intended for diagnostic claims. Any diagnostic assessment should always be made by the attending physician, based on the evaluation of all sources of clinical, endoscopic and other relevant information. The use of sodium fluorescein with the Cellvizio system is not cleared for the use by the United States Food and Drug Administration, but has been used on the basis of its prevalence and acceptance in peer reviewed literature.