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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 K052412
Device Name INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ
Applicant
Ge Healthcare
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact LARRY A KROGER
Correspondent
Intertek Testing Services
70 Codman Hill Rd.
Boxborough,  MA  01719
Correspondent Contact DANIEL W LEHTONEN
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received09/02/2005
Decision Date 09/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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