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 IDK191008
510k NumberK191008
Device Name:ILab Polaris Multi-Modality Guidance System
ClassificationComputer, Diagnostic, Programmable
Applicant Boston Scientific Corporation 150 Baytech Drive San Jose,  CA  95134
ContactMugdha Dongre
CorrespondentMugdha Dongre
Boston Scientific Corporation 150 Baytech Drive San Jose,  CA  95134
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 Received2019-04-16
Decision Date2019-07-02

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