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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 K162224
Device Name ArtPix Mobile EZ2GO
Applicant
Cmt Medical Technologies, Ltd.
Hacarmel St. Bld 7/2, Pob 111
Industrial Park
Yoqneam Ilit,  IL 20692
Applicant Contact LILIA SCHLOSBERG
Correspondent
Cmt Medical Technologies, Ltd.
Hacarmel St. Bld 7/2, Pob 111
Industrial Park
Yoqneam Ilit,  IL 20692
Correspondent Contact LILIA SCHLOSBERG
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received08/08/2016
Decision Date 09/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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