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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,  IS 44425
Original Contact ahava stein
Regulation Number892.1200
Classification Product Code
KPS  
Date Received09/04/2007
Decision Date 10/01/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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