Mauna Kea Technologies receives FDA 510(k) clearance for new Cellvizio system

Mauna Kea Technologies, a global medical device company, has received FDA 510(k) clearance for its new Cellvizio system that functions at a near-infrared wavelength of 785 nanometers.

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Carrie Pallardy

The new version of the Cellvizio endomicroscopy technology is designed to be capable of a broader range of microscopic tissue analysis.

The Cellvizio system is compatible with most endoscopes. The FDA 510(k) clearance and CE Marking clear the device for use in the GI tract and urinary and respiratory systems.

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