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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 K110849
Device Name PRESTODR 4143
Applicant
Cmt Medical Technologies, Ltd.
Industrial Park
P.O.B. 111
Yoqneam Ilit,  IL 20692
Applicant Contact SHLOMI DINES
Correspondent
Cmt Medical Technologies, Ltd.
Industrial Park
P.O.B. 111
Yoqneam Ilit,  IL 20692
Correspondent Contact SHLOMI DINES
Regulation Number892.1680
Classification Product Code
KPR  
Date Received03/28/2011
Decision Date 04/26/2011
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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