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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
Device Name DISCOVERY MODEL NM/CT 670
Original Applicant
GE MEDICAL SYSTEMS F.I. HAIFA
4 hayozma st.
tirat hacarmel,  IL 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 (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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