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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 K122298
Device Name AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR
Applicant
Ajex Meditech., Ltd.
52 Newtown Plaza
Plainview,  NY  11803
Applicant Contact WILLIAM LITTLE
Correspondent
Ajex Meditech., Ltd.
52 Newtown Plaza
Plainview,  NY  11803
Correspondent Contact WILLIAM LITTLE
Regulation Number892.1720
Classification Product Code
IZL  
Date Received07/31/2012
Decision Date 03/28/2014
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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