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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 K043381
Device Name INFINIA LIGHTSPEED
Applicant
GE MEDICAL SYSTEMS F.I. HAIFA
4 HAYOZMA ST.
TIRAT HACARMEL,  IL 30200
Applicant Contact LAURENCE BIGIO
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact ALEX GROB
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received12/09/2004
Decision Date 12/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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