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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 K030420
Device Name LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
Applicant
GE MEDICAL SYSTEMS
3000 NORTH GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact JOHN W JAECKLE
Correspondent
GE MEDICAL SYSTEMS
3000 NORTH GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Correspondent Contact JOHN W JAECKLE
Regulation Number892.1750
Classification Product Code
JAK  
Date Received02/10/2003
Decision Date 03/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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