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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 K093514
Model NM/CT 670
Device Name DISCOVERY MODEL NM/CT 670
Original Applicant
GE MEDICAL SYSTEMS F.I. HAIFA
4 hayozma st.
tirat hacarmel,  IS 30200
Original Contact eli werner
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received11/13/2009
Decision Date 12/10/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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