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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 K991896
Device Name MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA
Applicant
GE MEDICAL SYSTEMS F.I. HAIFA
P.O. BOX 170
TIRAT HACARMEL,  IL 30200
Applicant Contact LAOR DAN
Correspondent
GE MEDICAL SYSTEMS F.I. HAIFA
P.O. BOX 170
TIRAT HACARMEL,  IL 30200
Correspondent Contact LAOR DAN
Regulation Number892.1200
Classification Product Code
KPS  
Date Received06/03/1999
Decision Date 08/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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