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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 K012836
Device Name MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM
Applicant
GE MEDICAL SYSTEMS
P.O. BOX 414
MILWAUKEE,  WI  53188
Applicant Contact LARRY A KROGER
Correspondent
GE MEDICAL SYSTEMS
P.O. BOX 414
MILWAUKEE,  WI  53188
Correspondent Contact LARRY A KROGER
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/23/2001
Decision Date 09/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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