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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K211191
Device Name Virtual C DRF Digital Imaging System
Applicant
Portavision Medical, LLC
800 Central Ave.
Jefferson,  LA  70121
Applicant Contact Terry Ancar
Correspondent
Kamm and Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received04/21/2021
Decision Date 06/24/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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