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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 K121019
Device Name OPTIMA NM/CT 640
Applicant
GE HEALTHCARE
4 HAYOZMA STREET
TIRAT HACARMEL,  IL 30200
Applicant Contact ELI WERNER
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received04/04/2012
Decision Date 04/19/2012
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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