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 IDK210889
510k NumberK210889
Device Name:ILab Polaris Multi-Modality Guidance System
ClassificationComputer, Diagnostic, Programmable
Applicant Boston Scientific Corporation Three Scimed Place Maple Grove Hennepin,  MN  55311
ContactRochell Aranha
CorrespondentRochell Aranha
Boston Scientific Corporation Three Scimed Place Maple Grove Hennepin,  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 Received2021-03-25
Decision Date2021-06-25

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