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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 K072468
Device Name MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM
Original Applicant
SPECTRUM DYNAMICS LTD.
20 hata'as st.
kfar saba,  IL 44425
Original Contact ahava stein
Regulation Number892.1200
Classification Product Code
KPS  
Date Received09/04/2007
Decision Date 10/01/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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