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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, Mobile
510(k) Number K244049
Device Name Europa (Alternative: AiRTouch) portable X-ray system
Applicant
Livermoretech, Inc.
801 N. Jupiter Rd. Suite 200
Plano,  TX  75074
Applicant Contact Casey Lee
Correspondent
Mtech Group, LLC
7505 Fannin St. Suite 610
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number892.1720
Classification Product Code
IZL  
Date Received12/31/2024
Decision Date 05/28/2025
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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