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K Number
K111047Device Name
CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES
Manufacturer
MAUNA KEA TECHNOLOGIES INC.
Date Cleared
2011-08-08
(115 days)
Product Code
OWN
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MAUNA KEA TECHNOLOGIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
Device Description
Cellvizio® 100 Series is a confocal laser imaging system with a variety of fiber optic probes (Confocal Miniprobes™) that is intended to allow confocal laser imaging of the internal microstructure of tissues in anatomical tracts, i.e. gastrointestinal or respiratory, accessed through an endoscope. Cellvizio® 100 Series is based on a common laser scanning technology adapted for imaging through a bundle of optical fibers which is the raw component of the Confocal Miniprobes™. Cellvizio® 100 Series is composed of several components, including: Main opto-electronical components: Laser Scanning Unit (LSU) Confocal Miniprobes™ Confocal Processor with Cellvizio® Software Peripherals: Foot-switch Keyboard Trackball Screen Video converter lsolation transformer User documentation: Cellvizio® 100 Series System User Guide, Confocal Miniprobes™ User Guide and Reprocessing Instructions Accessories (such as Cletop-S Confocal Miniprobes™ connector cleaning system, Confocal Miniprobes™ clip, storage box, caps, späre fuses) All components are integrated into a cart.
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