K-number	K201178
Device name	iLab Polaris Multi-Modality Guidance System
Applicant	Boston Scientific
Product code	DQK
Device class	Class II
Decision date	May 29, 2020
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.