DA VINCI FLUORESCENCE IMAGING VISION SYSTEM

Confocal Optical Imaging

INTUITIVE SURGICAL, INC.

The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Da Vinci Fluorescence Imaging Vision System.

Pre-market Notification Details

Device IDK124031
510k NumberK124031
Device Name:DA VINCI FLUORESCENCE IMAGING VISION SYSTEM
ClassificationConfocal Optical Imaging
Applicant INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BUILDING 101 Sunnyvale,  CA  94086 -5206
ContactCindy Domecus
CorrespondentCindy Domecus
INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BUILDING 101 Sunnyvale,  CA  94086 -5206
Product CodeOWN  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2012-12-28
Decision Date2013-09-13
Summary:summary

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