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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 K003264
Device Name QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION
Applicant
GE MEDICAL SYSTEMS F.I. HAIFA
10 HAYOZMA ST., P.O. BOX 170
TIRAT HACARMEL,  IL 30200
Applicant Contact DAN LAOR
Correspondent
GE MEDICAL SYSTEMS F.I. HAIFA
10 HAYOZMA ST., P.O. BOX 170
TIRAT HACARMEL,  IL 30200
Correspondent Contact DAN LAOR
Regulation Number892.1200
Classification Product Code
KPS  
Date Received10/18/2000
Decision Date 12/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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