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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
Device Name GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM
Applicant
GE HEALTHCARE
9900 Innovation Drive
Wauwatosa,  WI  53226
Applicant Contact CAROL ALLOIAN
Correspondent
GE HEALTHCARE
9900 Innovation Drive
Wauwatosa,  WI  53226
Correspondent Contact CAROL ALLOIAN
Regulation Number892.1600
Classification Product Code
IZI  
Date Received10/11/2011
Decision Date 12/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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