ILab Polaris Multi-Modality Guidance System

Computer, Diagnostic, Programmable

Boston Scientific

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

Pre-market Notification Details

Device IDK201178
510k NumberK201178
Device Name:ILab Polaris Multi-Modality Guidance System
ClassificationComputer, Diagnostic, Programmable
Applicant Boston Scientific Three Scimed Place Maple Grove,  MN  55311
ContactKevin Lam
CorrespondentKevin Lam
Boston Scientific Three Scimed Place Maple Grove,  MN  55311
Product CodeDQK  
Subsequent Product CodeDSK
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-01
Decision Date2020-05-29

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