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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, imaging, optical coherence tomography (oct)
510(k) Number K192922
Device Name Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
Gentuity, LLC
142 North Road, Suite G
Sudbury,  MA  01776
Applicant Contact David Kolstad
Mandell Horwitz Consultants LLC
5 Lake Como Ct.
Greenville,  SC  29609
Correspondent Contact Diane Horwitz
Regulation Number892.1560
Classification Product Code
Subsequent Product Code
Date Received10/16/2019
Decision Date 02/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No