K-number	K191008
Device name	iLab Polaris Multi-Modality Guidance System
Applicant	Boston Scientific Corporation
Product code	DQK
Device class	Class II
Decision date	Jul 2, 2019
Decision	Substantially Equivalent
Regulation	870.1425

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Source

View the full FDA submission: accessdata.fda.gov

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iLab Polaris Multi-Modality Guidance System

Everything you need for a 510(k) submission. Nothing you don't.