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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K110507
Device Name CARDIAC SCANNER AND PROCESSING SYSTEM
Applicant
Spectrum Dynamics (Israel) , Ltd.
1 Ha'Rakefet St.
Zichron Yaacov,  IL 30900
Applicant Contact ILAN SHARON
Correspondent
Spectrum Dynamics (Israel) , Ltd.
1 Ha'Rakefet St.
Zichron Yaacov,  IL 30900
Correspondent Contact ILAN SHARON
Regulation Number892.1200
Classification Product Code
KPS  
Date Received02/22/2011
Decision Date 07/13/2011
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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