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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(K) Number K121200
Model S18021LC, S18021LB
Device Name FLIGHTPLAN FOR LIVER
Applicant
GE HEALTHCARE
9900 w innovation dr
wauwatosa,  WI  53226 4856
Contact carol alloian
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/19/2012
Decision Date 11/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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