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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 K242239
Device Name HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))
Applicant
Gentuity, LLC
142 N. Rd.
Suite G
Sudbury,  MA  01776
Applicant Contact Edwin Rule
Correspondent
Gentuity, LLC
142 N. Rd.
Suite G
Sudbury,  MA  01776
Correspondent Contact Sharon Timberlake
Regulation Number892.1560
Classification Product Code
NQQ  
Subsequent Product Code
DQO  
Date Received07/30/2024
Decision Date 08/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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