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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K160857
Device Name HF 718BD X-Ray System
Applicant
Arquilla, Inc. Dba X-Cel X-Ray Corporation
5220 Waller St. Suite 1
Crystal Lake,  IL  60012
Applicant Contact GUIDO ARQUILLA
Correspondent
Cjp Consulting, Inc.
5831 N Kostner Ave.
Chicago,  IL  60646
Correspondent Contact Cynthia J. Pillar
Regulation Number892.1680
Classification Product Code
KPR  
Date Received03/29/2016
Decision Date 02/24/2017
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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