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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K003438
Device Name SMART RAD
Applicant
CMT MEDICAL TECHNOLOGIES, LTD.
MATAM HIGH TECHNOLOGY CENTER
HAIFA,  IL 31905
Applicant Contact YESHAYAHU RAZ
Correspondent
CMT MEDICAL TECHNOLOGIES, LTD.
MATAM HIGH TECHNOLOGY CENTER
HAIFA,  IL 31905
Correspondent Contact YESHAYAHU RAZ
Regulation Number892.1680
Classification Product Code
MQB  
Date Received11/06/2000
Decision Date 07/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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