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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K080890
Device Name SMARTSPOT PRIMAX
Applicant
Cmt Medical Technologies, Ltd.
6 Sireni
Haifa,  IL 32972
Applicant Contact DAN LAOR
Correspondent
Cmt Medical Technologies, Ltd.
6 Sireni
Haifa,  IL 32972
Correspondent Contact DAN LAOR
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/31/2008
Decision Date 04/29/2008
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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