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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, Extraoral Source, Digital
510(k) Number K232255
Device Name EZSensor XHD
Applicant
Qpix Solutions, Inc.
1001 Aviation Pkwy., Suite 200
Morrisville,  NC  27560
Applicant Contact Seungman Yun
Correspondent
Mtech Group, LLC
7505 Fannin St. Suite 610
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number872.1800
Classification Product Code
MUH  
Date Received07/28/2023
Decision Date 09/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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