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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K092004
Device Name GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ
Applicant
Ge Healthcare
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact ALAN TOTAH
Correspondent
Ge Healthcare
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact ALAN TOTAH
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
IZI   JAA  
Date Received07/02/2009
Decision Date 08/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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