ILab Polaris Multi-Modality Guidance System

Computer, Diagnostic, Programmable

BOSTON SCIENTIFIC CORPORATION

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Ilab Polaris Multi-modality Guidance System.

Pre-market Notification Details

Device IDK151613
510k NumberK151613
Device Name:ILab Polaris Multi-Modality Guidance System
ClassificationComputer, Diagnostic, Programmable
Applicant BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE Maple Grove,  MN  55311
ContactArlene Roche
CorrespondentArlene Roche
BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE Maple Grove,  MN  55311
Product CodeDQK  
Subsequent Product CodeDSK
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-15
Decision Date2015-10-06
Summary:summary

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