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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, angiographic
510(k) Number K113034
Models INNOVA 21001Q, INNOVA 41001Q,INNOVA 31001Q,
Device Name GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM
Original Applicant
GE HEALTHCARE
9900 innovation drive
wauwatosa,  WI  53226
Original Contact carol alloian
Regulation Number892.1600
Classification Product Code
IZI  
Date Received10/11/2011
Decision Date 12/13/2011
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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