K-number	K230620
Device name	Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
Applicant	Gentuity, LLC
Product code	DQO
Device class	Class II
Decision date	Aug 8, 2023
Decision	Substantially Equivalent
Regulation	870.1200

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Source

View the full FDA submission: accessdata.fda.gov

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Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter

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