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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
Applicant
Gentuity, LLC
142 N. Rd.
Suite G
Sudbury,  MA  01776
Applicant Contact David Kolstad
Correspondent
Mandell Horwitz Consultants, LLC
5 Lake Como Ct.
Greenville,  SC  29609
Correspondent Contact Diane Horwitz
Regulation Number892.1560
Classification Product Code
NQQ  
Subsequent Product Code
ORD  
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
Predetermined Change
Control Plan Authorized		 No
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