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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 K212523
Device Name VFSS Pro Mobile Digital Imaging System
Applicant
Imagexray, LLC
160 Park Ave.
Nutley,  NJ  07110
Applicant Contact Gary Korkola
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO   QHY   RCC  
Date Received08/11/2021
Decision Date 11/05/2021
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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