FDAnews
www.fdanews.com/articles/81359-fda-510k-approval-for-cellvizio-gi-new-advanced-endoscopic-imaging-system

FDA 510K APPROVAL FOR CELLVIZIO-GI NEW ADVANCED ENDOSCOPIC IMAGING SYSTEM

October 3, 2005

Mauna Kea Technologies, specialized in the development of in vivo cellular imaging for biomedical and medical applications, recently announced that it received a 510 k approval from FDA to market the Cellvizio-GI (known previously as the F400 system). Designed to be used in conjunction with conventional video-endoscopes, this new advanced confocal laser imaging system allows real-time microscopic observations of tissues in the gastrointestinal tract.

Medical News Today (http://www.medicalnewstoday.com/medicalnews.php?newsid=31321)