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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, tomography, computed
510(k) Number K091673
Device Name GE LIGHTSPEED ACT FP16
Applicant
GE MEDICAL SYSTEMS, INC.
3000 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact ALLEN SCHUH
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
JAA  
Date Received06/09/2009
Decision Date 06/24/2009
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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